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  • Director, Global Quality GMP Processes

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Quality manager job in Lansing, MI

    The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: + Product Quality Complaints + Corrective and Preventive Actions (CAPA) + Deviations + Management Reporting and Trending + Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. + Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. + Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. + Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. + Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. **Qualifications** Required **Required Qualifications:** + Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. + Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). + Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. + Strong analytical and problem-solving skills with a data-driven mindset. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. + Ability to travel internationally as needed. Preferred + Basic understanding of artificial intelligence and advanced analytics + Experience supporting risk management programs or frameworks. + Familiarity with quality management systems and digital tools. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $183.3k yearly 33d ago
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  • Quality-Manufacturing

    Technique Inc.

    Quality manager job in Jackson, MI

    DEPARTMENT: Quality Control SUPERVISED BY: Quality Director STATUS: Full time non-exempt Technique, Inc. is a Michigan-based stamping, tubing and welding facility offering the shortest lead-times and highest quality parts in the industry. We offer high-speed prototypes, ultra-low volume stampings, tubing and assemblies for production and emergency-based manufacturing for industries such as aerospace, automotive, medical and food processing. Technique, Inc. is a group of highly skilled technicians who consistently strive to improve the tools, technology and processes which allow us to continue growing at an incredible rate. The company is dedicated to the success of each team member in a culture that values safety, integrity, teamwork, learning opportunities and results. Position Summary: This position is responsible for inspecting components and finished products to determine compliance with engineering requirements. The employee will also create and maintain all documentation, as well as assist with dispositioning nonconforming product. The employee will develop procedures and coordinate efforts for quality system compliance. They will lead quality/continuous improvement projects in coordination with account managers and purchasing department, and work with setup technicians, customers and vendors on quality-related issues. Essential Job Functions: Use precision measuring tools to check parts against blueprints Assemble and submit PPAP, first piece inspection, source releases, and quality packages documentation. Use/write programs in PolyWorks to operate CMM machines Calibrate precision machinery Work with technicians to provide legible feedback per blueprint specifications and assist technicians with part development Create and complete customer documentation Reverse engineer to help with process improvement activities and corrective actions Professionally represent Technique when interacting with customer representatives Qualifications: EDUCATION: Associate's degree in engineering technology or related field preferred CREDENTIALS/LICENSURE: forklift operator's license preferred MINIMUM EXPERIENCE: 2-4 years of quality control in manufacturing/engineering environment Position Requirements (Skills & Abilities): Ability to multitask in a fast-paced environment Good understanding of GD&T and blueprints Strong communication, time management, and computer skills Experience in an ISO 9000 environment Experience using PolyWorks and SolidWorks Root cause analysis/problem solving skills Ability to use CAD and SolidWorks Ability to use precision measurement tools Travel No travel is required for this position. Other Duties Please note this job description is not designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Minimum Physical Expectations: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day. The employee must frequently lift and/or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Position Type and Expected Hours: This is a full-time non-exempt position with a minimum of 40hrs / week with overtime as needed. Note: days and hours required may vary. Shifts include 1st - Monday-Friday - 7:00am-3:30pm Environmental Expectations: While performing the duties of this job, the employee is frequently exposed to manufacturing processes that include and are not limited to; fumes or airborne particles, hazardous chemicals, moving mechanical parts, industrial equipment, and vibration. The noise level in the work environment can be loud. EEO Statement Technique, Inc., is an equal employment opportunity employer. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Authorization Employee must be eligible to work in the United States, either by means of U.S. Citizenship, Work Visa or H1B sponsorship. E-Verify partner employer. Powered by JazzHR zVN71MzHVG
    $90k-141k yearly est. 9d ago
  • Director, Quality - Life Sciences

    Datavant

    Quality manager job in Lansing, MI

    Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. **What You Will Do** + Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. + Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. + Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. + Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. + Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). + Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. + Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. + Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. **What You Need to Succeed** + 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. + Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** . + Experience managing and mentoring cross-functional teams. + Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** . + Deep understanding of **data governance, privacy, and security** best practices. + Experience interacting with external auditors, customer compliance teams, or regulatory agencies. + Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. **What Helps You Stand Out** + Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. + Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. + Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). + Experience contributing to industry working groups on quality, data integrity, or health data compliance. \#LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .
    $165k-230k yearly 40d ago
  • Quality Manager

    American Rheinmetall

    Quality manager job in Lansing, MI

    American Rheinmetall is a leader in the design, development, and production of advanced tracked and wheeled vehicles, vehicle systems, and critical components that support U.S. military modernization. Our expertise spans electronic and mechanical systems, fabricated structures, armored products, rubber solutions, and track systems, delivering reliable innovation to both defense and commercial markets. As part of the global Rheinmetall family, we combine proven heritage with forward-looking technology to provide solutions that defend and feed the world. Job Summary: The Quality Manager is responsible for planning, coordinating, and directing all aspects of the company's quality program to ensure that products meet or exceed established standards and customer expectations. This role oversees quality control, quality assurance, and compliance processes, and works closely with production, engineering, and customers to support continuous improvement. The Quality Manager reports to the Vice President of Quality and leads the Quality Department staff. Essential Functions: Develop and maintain quality objectives that align with corporate policies and goals. Communicate and interpret quality philosophy, standards, and expectations to key personnel across the organization. Track and monitor performance using Key Performance Indicators (KPIs) to identify trends, issues, and improvement opportunities. Manage and drive the Corrective and Preventive Action (CAPA) process. Develop and implement standards, procedures, and methods for inspection, testing, and evaluation of materials and products. Plan and oversee inspection, analysis, design, and testing to ensure compliance and quality of products and components. Review design documentation, vendor quality manuals, and company quality records for adherence to requirements. Represent the company during customer visits, audits, and presentations, both onsite and at customer locations. Review and analyze quality control and quality assurance data for consistency with company standards and compliance requirements. Keep management informed of significant quality issues, root causes, and actions being taken. Prepare and present technical and program-related information to the management team. Direct and support quality staff in inspection and testing activities to ensure continuous control over materials, facilities, and products. Maintain up-to-date knowledge of government and industry quality codes and standards (e.g., AS9100, ISO). Develop and deliver quality training programs for employees in coordination with department managers. Utilize ERP systems (PLEX preferred) to manage and support quality processes. Supervisory Responsibility: Yes - directly supervises employees in the Quality Department, including interviewing, hiring, training, assigning work, appraising performance, rewarding and disciplining employees, and addressing complaints and resolving problems in accordance with company policies and laws. Minimum Qualifications: Knowledge, Skills and Abilities (as demonstrated through experience, training and/or testing) Strong understanding of quality assurance principles, inspection/testing methods, and compliance standards. Leadership skills to effectively manage, mentor, and develop quality staff. Proficiency in root cause analysis, corrective/preventive action, and continuous improvement processes. Ability to interpret technical specifications, engineering documentation, and quality standards. Strong interpersonal and communication skills for collaboration with internal teams, suppliers, and customers. Knowledge of quality systems and requirements including AS9100 and ISO14001. Familiarity with ERP systems (PLEX preferred) for quality and compliance management. Education: Bachelor's degree in engineering, management, or business required. Experience: Minimum of eight (8) years' experience in quality assurance engineering or management. At least two (2) years of management/supervisory experience required. Equivalent combination of education and experience will be considered. Background Prerequisites: Must undergo and meet company standards for background check, employment verification, reference checks and controlled substance testing. Preferred Qualifications: Advanced degree or certifications such as ASQ Certified Quality Engineer (CQE) or Certified Quality Manager (CQM). Aerospace or defense industry quality experience. Hands-on experience with lean manufacturing and Six Sigma methodologies. Working Conditions and Physical Demands: With or without reasonable accommodations, requires the physical and mental capacity to perform effectively all essential functions. In addition to other demands, the demands of the job include: Occasionally stand, walk, sit, use hands to handle or feel, and reach with arms. Occasionally lift and/or move up to 50 pounds. Work in both office and manufacturing floor environments with exposure to noise, machinery, and inspection/testing equipment. PPE required in designated areas. Equal Employment Opportunity Statement: American Rheinmetall provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sex (including pregnancy), gender identity, national origin, age, disability, or marital status, in accordance with applicable federal, state and local laws. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
    $73k-116k yearly est. 2d ago
  • Manager, Data Quality

    Dodge Construction Network

    Quality manager job in Lansing, MI

    The Manager, Data Quality, is responsible for overseeing the full data management lifecycle and operational workflow of Company Entity Management (CEM) for company and contact data within Dodge Construction Network's (Dodge) master data ecosystem. This role leads both onshore and offshore teams to ensure the accuracy, completeness, and standardization of company entities that power Dodge's products, customer experiences, and analytics. The Manager will define and execute the end-to-end operating model for CEM including the development of Standard Operating Procedures (SOPs), establishing KPIs, designing quality and governance frameworks, and defining requirements for automation and human-in-the-loop workflows. This role drives continuous improvement by refining processes, enhancing data sourcing and enrichment, evaluating automation outputs, and collaborating closely with cross-functional partners across Product, Engineering, and Operations. This leader must bring strong people management and project management skills, an analytical mindset, and have experience working in scalable data operations environments. This is a full-time position and reports directly to the Director of Data Acquisition. **_Preferred Location_** + This is a remote, home-office-based role, and candidates located in the continental United States will be considered. + For this position, there is a preference to hire in the Central and Eastern Time Zone; however, candidates in other areas/time zones would be considered as well. **_Travel Requirements_** Expected travel is minor for this role. **_Essential Functions_** + Design, maintain, and improve company and contact entity workflows, SOPs, SLAs, and quality standards + Define and track KPIs for team efficiency, business impact, financial stewardship, and client satisfaction + Oversee entity creation, updates, merges, conflict resolution, and exception handling + Partner with automation, engineering, and data science to integrate and optimize human-in-the-loop and machine-assisted processes + Analyze performance patterns to identify automation gaps, reduce manual interventions, and continuously improve processes + Lead, mentor, and develop CEM team members + Establish performance expectations, work allocation, and capacity planning + Manage relationships with third party data providers and offshore vendors + Collaborate closely with Engineering, Product, Sourcing, and Sales to align CEM standards with business and platform needs + Participate in roadmap discussions, attribute model design, and classification/taxonomy updates **_Education Requirement_** Bachelor's degree in Information Systems, Data Analytics, Supply Chain Management, Computer Science, Engineering, Operational Management, or related technical fields or equivalent education and work experience. **_Required Experience, Knowledge and Skills_** + 7+ years of experience in data operations, master data management, digital operations, or business transformation + 2+ years managing teams + Proven experience managing both onshore and offshore teams + Experience with SQL and/or Python programming + Advanced problem solving and data driven decision making capabilities + Proven record of managing external vendor relationships + Ability to translate technical concepts into actional business insights for non-technical stakeholders + Experience with automation tools, scraping frameworks, and data pipelines + Exposure to data operations utilizing machine learning and data enrichment techniques + Proficiency in data governance, KPI management, and quality assurance + Strong project management skills, including planning, prioritization, and execution of change management + Excellent written and verbal communication skills for presenting strategies, reporting performance metrics, and building relationships with stakeholders **_Preferred Experience, Knowledge and Skills_** + Data Visualization tools such as AWS Quicksight, PowerBI, Tableau + Knowledge of construction industry or content workflows a plus + Experience with salesforce a plus + Familiarity with cloud-based data environments + Familiarity with Jira/Confluence **_About Dodge Construction Network_** Dodge Construction Network exists to deliver the comprehensive data and connections the construction industry needs to build thriving communities. Our legacy is deeply rooted in empowering our customers with transformative insights, igniting their journey towards unparalleled business expansion and success. We serve decision-makers who seek reliable growth and who value relationships built on trust and quality. By combining our proprietary data with cutting-edge software, we deliver to our customers the essential intelligence needed to excel within their respective landscapes. We propel the construction industry forward by transforming data into tangible guidance, driving unparalleled advancement. Dodge is the catalyst for modern construction. **_Salary Disclosure_** Dodge Construction Network's compensation and rewards package for full time roles includes a market competitive salary, comprehensive benefits, and, for applicable roles, uncapped commissions plans or an annual discretionary performance bonus. **_For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status._** **_A background check is required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job and consistent with all federal state and local ordinances._** **_Reasonable Accommodation_** **_Dodge Construction Network is committed to recruiting, hiring, and promoting people with disabilities. If you need an accommodation or assistance completing the online application, please email_** **_***************************_** **_._** **_Equal Employment Opportunity Statement_** **_Dodge Construction Network is an Equal Opportunity Employer. We are committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All employment decisions shall be based on merit, qualifications, and business needs without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law._** \#LI-Remote \#LI-CS1 \#DE-Remote \#DE-2026-22
    $73k-116k yearly est. 9d ago
  • Quality Manager

    Provision People

    Quality manager job in Lansing, MI

    Our award-winning client is searching for a Quality Manager to perform all duties, as needed for the Quality Department. Responsibilities: Know and analyze the specific customer requirements, processes and products understanding how much our failure modes can impact the customer lines and final products. Track customer indicators, generate corrective action plans with the plant teammates when needed. Monitor and advise the plants so that we have OEM inspection implemented, understood, and practiced. Ensure that all past problems are converted into lessons learned for engineering, process, tooling, production, and quality plant manager teams. Required Qualifications: Bachelor's degree Technical Current or recent Quality Manager(3+ years as QM) with a progressive career in quality(preferably at a Tier 1 automotive plant) - PPAP audits, ISO 9000 experience, etc. PPAP Audit experience required. Strong ITAF experience required. Quality or equivalent - 8 years Supplier management Project management WPS and lean manufacturing knowledge Intermediate English - written and oral MS Project Good skills with office tools
    $73k-116k yearly est. 60d+ ago
  • Quality Manager

    Bleistahl North America LP

    Quality manager job in Battle Creek, MI

    Job DescriptionDescription: Job title: Quality Manager Reports to: Managing Director Assures consistent quality of production by developing and enforcing good automated manufacturing practice (GAMP) systems; validating processes; providing documentation; managing staff. Key Responsibilities Communicate with customers as needed to resolve quality issues Work with engineering, manufacturing and other functional area to resolve customer, internal and/or supplier quality issues Support manufacturing to ensure conformance to the company's processes, as well as customer specific processes and requirements Manages APQP practices in support of new program launches including customer specific approval processes (PPAP, ISIR, etc) Manages in implementing QS, TS and IATF in the facility Manages the reading and interpretation of customer part and component drawings including GD&T, customer quality standards, and/or requirements Lead manufacturing facility in 8D Problem solving activities, in conjunction with collaborating with customer Demonstrate ability to initiate and accomplish assigned tasks in a manufacturing environment where priorities may change Responsible for performing sub supplier audits as needed Manages a team of quality techs to ensure process and quality standards are met Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. Requirements: Required Qualifications Bachelor's degree in Engineering or equivalent in experience 3 -5 year of quality engineering experience Working knowledge of MS Windows/Office Excellent communication skills (verbal and written), organized and time management skills Ability to prioritize work load Establish and reach work goals in accordance to the direction established by customer and manufacturing Ability to travel nationally and internationally (25%) Physical Demands Required to stand for long periods of time and move about the facility Occasional lifting of items not to exceed 50 lbs Required to use safety glasses while performing specific tasks or while in specific areas of the plant Work Environment Works primarily in a plant environment Exposed to any number of elements. Other Perform other duties as assigned. Process Owner Process owners should ensure should ensure their processes: Describe its links and interactions with other processes Identify its documentation and training requirements Issue and maintain any procedures and instructions Implement processes consistent with the quality policy Make available necessary resources and information Operate and control an effective and efficient process Resolve any problems and prevent their recurrence Communicate process changes to the process users Define and manage interfaces with other processes Communicate input requirements to internal suppliers Meet the output requirements of internal customers Analyze performance data and set quality objectives Track progress against process performance targets Communicate with process users to identify issues Identify risks and opportunities with current process Investigate and propose process improvements Ensure all corrective action that are assigned to their process are completed in a timely manner
    $72k-114k yearly est. 29d ago
  • Program Manager, Product Quality and Readiness

    Rivian 4.1company rating

    Quality manager job in Plymouth, MI

    About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and operate comfortably in areas that are unknown. Our backgrounds are diverse, but our team shares a love of the outdoors and a desire to protect it for future generations. Role Summary At Rivian, handing over the keys isn't just a transaction; it is the start of an adventure. As the Program Manager, Product Quality & Readiness, you are the guardian of that standard. You are a strategic operator and systems thinker obsessed with defining the technical frameworks and quality gates that ensure every vehicle delivered to a customer is flawless in both function and form. You operate at the critical junction where the factory ends and the customer journey begins. Your mission is to architect the intelligent, scalable operating system that performs the final validation of our vehicles before they ever reach a customer's driveway. You ensure that the first moment of ownership is pure joy, unmarred by technical oversight or cosmetic imperfection. More critically, you will transform this validation phase into the ultimate feedback loop. You will capture high-fidelity data to drive systemic improvements in the factory, while simultaneously driving rigorous operational execution in the field to ensure vehicle presentation is immaculate. You are the operational bridge ensuring quality is a closed-loop system that centers the customer at every stage. Responsibilities The Customer Advocate: You never lose sight of the human being waiting for their keys. You view every defect-whether a software bug or a smudge on the glass-as a potential friction point in a customer's adventure, and you fight relentlessly to eliminate them. The Clarity Creator: You are an expert at simplifying complex quality challenges into structured, measurable technical programs. The Data Architect: You use data to diagnose systemic issues, build compelling business cases, and ensure every requirement is backed by measurable field impact. The Strategic Partner: You excel at translating field reality into actionable HQ plans, fostering alignment and shared success with central teams, especially Manufacturing. A Long-Term Builder: You are focused on building sustainable, scalable systems that will power our quality standards for years to come. Qualifications 8+ years of experience in Technical Program Management, Product, Process/Industrial Engineering, or Operations within a complex hardware-intensive industry (Automotive, Aerospace, or similar). This requirement is reduced to 5 years for candidates with a Master's degree. Customer Obsession: A demonstrated ability to connect technical processes to customer outcomes. You understand that "Quality" is defined by the user experience, not just the spec sheet. Operational Rigor: Experience defining Standard Operating Procedures (SOPs) for field or factory teams. You understand that while the factory builds the product, the field team delivers the experience, and you know how to drive compliance in product presentation, quality, and cleanliness. Proven experience in defining, deploying, and owning technical systems and data pipelines, specifically around quality control, manufacturing execution (MES), or diagnostic tooling. Exceptional ability to synthesize high-volume data (telemetry, manufacturing data) into clear, strategic narratives for both executive and engineering audiences. The Operator-Engineer Mindset: You are equal parts operator (focused on execution, logistics, and people) and engineer (focused on systems, optimization, and tools). Applied Ingenuity: A degree in a hands-on technical field is preferred. However, we value applied ingenuity above all; a demonstrated track record of solving complex problems in rigorous environments may be accepted in lieu of specific academic credentials. Pay Disclosure Salary Range/Hourly Rate for California Based Applicants: $121,800 - $161,450 (actual compensation will be determined based on experience, location, and other factors permitted by law). Benefits Summary: Rivian provides robust medical/Rx, dental and vision insurance packages for full-time and part-time employees, their spouse or domestic partner, and children up to age 26. Full Time Employee coverage is effective on the first day of employment. Part-Time employee coverage is effective the first of the month following 90 days of employment. Salary Range/Hourly Rate for Illinois Based Applicants: $102,300 - $135,580 (actual compensation will be determined based on experience, location, and other factors permitted by law). Benefits Summary: Rivian provides robust medical/Rx, dental and vision insurance packages for full-time and part-time employees, their spouse or domestic partner, and children up to age 26. Full Time Employee coverage is effective on the first day of employment. Part-Time employee coverage is effective the first of the month following 90 days of employment. Equal Opportunity Rivian is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, gender, gender expression, gender identity, genetic information or characteristics, physical or mental disability, marital/domestic partner status, age, military/veteran status, medical condition, or any other characteristic protected by law. Rivian is committed to ensuring that our hiring process is accessible for persons with disabilities. If you have a disability or limitation, such as those covered by the Americans with Disabilities Act, that requires accommodations to assist you in the search and application process, please email us at candidateaccommodations@rivian.com. Candidate Data Privacy Rivian may collect, use and disclose your personal information or personal data (within the meaning of the applicable data protection laws) when you apply for employment and/or participate in our recruitment processes ("Candidate Personal Data"). This data includes contact, demographic, communications, educational, professional, employment, social media/website, network/device, recruiting system usage/interaction, security and preference information. Rivian may use your Candidate Personal Data for the purposes of (i) tracking interactions with our recruiting system; (ii) carrying out, analyzing and improving our application and recruitment process, including assessing you and your application and conducting employment, background and reference checks; (iii) establishing an employment relationship or entering into an employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping; (vi) ensuring network and information security and preventing fraud; and (vii) as otherwise required or permitted by applicable law. Rivian may share your Candidate Personal Data with (i) internal personnel who have a need to know such information in order to perform their duties, including individuals on our People Team, Finance, Legal, and the team(s) with the position(s) for which you are applying; (ii) Rivian affiliates; and (iii) Rivian's service providers, including providers of background checks, staffing services, and cloud services. Rivian may transfer or store internationally your Candidate Personal Data, including to or in the United States, Canada, the United Kingdom, and the European Union and in the cloud, and this data may be subject to the laws and accessible to the courts, law enforcement and national security authorities of such jurisdictions. Please note that we are currently not accepting applications from third party application services. 8+ years of experience in Technical Program Management, Product, Process/Industrial Engineering, or Operations within a complex hardware-intensive industry (Automotive, Aerospace, or similar). This requirement is reduced to 5 years for candidates with a Master's degree. Customer Obsession: A demonstrated ability to connect technical processes to customer outcomes. You understand that "Quality" is defined by the user experience, not just the spec sheet. Operational Rigor: Experience defining Standard Operating Procedures (SOPs) for field or factory teams. You understand that while the factory builds the product, the field team delivers the experience, and you know how to drive compliance in product presentation, quality, and cleanliness. Proven experience in defining, deploying, and owning technical systems and data pipelines, specifically around quality control, manufacturing execution (MES), or diagnostic tooling. Exceptional ability to synthesize high-volume data (telemetry, manufacturing data) into clear, strategic narratives for both executive and engineering audiences. The Operator-Engineer Mindset: You are equal parts operator (focused on execution, logistics, and people) and engineer (focused on systems, optimization, and tools). Applied Ingenuity: A degree in a hands-on technical field is preferred. However, we value applied ingenuity above all; a demonstrated track record of solving complex problems in rigorous environments may be accepted in lieu of specific academic credentials. The Customer Advocate: You never lose sight of the human being waiting for their keys. You view every defect-whether a software bug or a smudge on the glass-as a potential friction point in a customer's adventure, and you fight relentlessly to eliminate them. The Clarity Creator: You are an expert at simplifying complex quality challenges into structured, measurable technical programs. The Data Architect: You use data to diagnose systemic issues, build compelling business cases, and ensure every requirement is backed by measurable field impact. The Strategic Partner: You excel at translating field reality into actionable HQ plans, fostering alignment and shared success with central teams, especially Manufacturing. A Long-Term Builder: You are focused on building sustainable, scalable systems that will power our quality standards for years to come.
    $121.8k-161.5k yearly 30d ago
  • Advance Quality Manager

    Clarios

    Quality manager job in Plymouth, MI

    **What you will do** + Provide quality leadership across the US organization in Advanced Quality Planning (AQP) management. + Ensure product quality and compliance throughout the development lifecycle, from prototype to ramp-up. + Deploy industry and customer-specific AQP standards and integrate ASPICE processes into automotive software development. + Lead quality planning for New Product Introductions (NPIs), including risk assessments, control plans, and validation protocols. + Drive issue resolution in design validation and manufacturing processes, reducing launch risks and Cost of Poor Quality (COPQ). **How you will do it** + Implement APQP, PPAP, and Core Tools to align quality strategies with lifecycle stages. + Utilize JAMA for requirements traceability and Jira for issue tracking and project management. + Review, challenge, and simplify test systems while applying quality-driven procedures. + Provide technical expertise in PFMEA, Control Plans, and Inspection Standards to mitigate risks. + Facilitate structured root cause analysis and coach cross-functional problem-solving teams. + Train and mentor team members on APQP procedures, Core Tools, and best practices. + Collaborate with internal and external stakeholders to ensure successful product launches and customer satisfaction. + Document and manage lessons learned to continuously improve processes and reduce COPQ. + Conduct all activities in compliance with company safety policies and procedures. **What we look for** Required + Bachelor's degree in Electrical Engineering, Chemical Engineering, Quality Management, or related field. + Minimum 5+ years of experience in quality management within automotive, electronics, or manufacturing industries. + Proven experience with APQP, PPAP, Core Tools, ASPICE implementation, and software quality processes. + Strong leadership and coaching abilities with excellent problem-solving and analytical skills. + Proficiency in quality methodologies (FMEA, SPC, MSA). + Experience with JAMA and Jira for requirements and issue management. + Effective communication and stakeholder management skills. Preferred + Master's degree in engineering or quality management. + Six Sigma Green/Black Belt certification. + ISO 9001/IATF 16949 auditor certifications. + ISO 26262 certification. + CQE (Certified Quality Engineer) certification. + Familiarity with AIAG/VDA Core Tools. **This position is not eligible for sponsorship.** \#LI-SG1 **What you get:** + Medical, dental and vision care coverage and a 401(k) savings plan with company matching - all starting on date of hire + Tuition reimbursement, perks, and discounts + Parental and caregiver leave programs + All the usual benefits such as paid time off, flexible spending, short-and long-term disability, basic life insurance, business travel insurance, Employee Assistance Program, and domestic partner benefits + Global market strength and worldwide market share leadership + HQ location earns LEED certification for sustainability plus a full-service cafeteria and workout facility + Clarios has been recognized as one of 2025's Most Ethical Companies by Ethisphere. This prestigious recognition marks the third consecutive year Clarios has received this distinction. **Who we are:** Clarios is the force behind the world's most recognizable car battery brands, powering vehicles from leading automakers like Ford, General Motors, Toyota, Honda, and Nissan. With 18,000 employees worldwide, we develop, manufacture, and distribute energy storage solutions while recovering, recycling, and reusing up to 99% of battery materials-setting the standard for sustainability in our industry. At Clarios, we're not just making batteries; we're shaping the future of sustainable transportation. Join our mission to innovate, push boundaries, and make a real impact. Discover your potential at Clarios-where your power meets endless possibilities. **Veterans/Military Spouses:** We value the leadership, adaptability, and technical expertise developed through military service. At Clarios, those capabilities thrive in an environment built on grit, ingenuity, and passion-where you can grow your career while helping to power progress worldwide. All qualified applicants will be considered without regard to protected characteristics. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please apply. Diversity of experience and skills combined with passion is key to challenging the status quo. Therefore, we encourage people from all backgrounds to apply to our positions. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran or other protected characteristics protected by law. As a federal contractor, we are committed to not discriminating against any applicant or employee based on these protected statuses. We will also take affirmative action to ensure equal employment opportunities. Please let us know if you require accommodations during the interview process by emailing Special.Accommodations@Clarios.com . We are an Equal Opportunity Employer and value diversity in our teams in terms of work experience, area of expertise, and all characteristics protected by laws in the countries where we operate. For more information on our commitment to sustainability, diversity, and equal opportunity, please read our latest report (********************************************** . We want you to know your rights (*********************************************************************************************** because EEO is the law. **A Note to Job Applicants:** please be aware of scams being perpetrated through the Internet and social media platforms. Clarios will never require a job applicant to pay money as part of the application or hiring process. **To all recruitment agencies** : Clarios does not accept unsolicited agency resumes/CVs. Please do not forward resumes/CVs to our careers email addresses, Clarios employees or any other company location. Clarios is not responsible for any fees related to unsolicited resumes/CVs. Clarios is the creator behind the world's most recognizable car battery brands. We are the car battery found in most new vehicles including leading brands such as Ford, General Motors, Toyota, Honda, and Nissan. Our 16,000 employees develop, manufacture, and distribute batteries for virtually every type of vehicle. We recover, recycle, and reuse up to 99% of our battery materials, leading sustainability practices in our industry. **A Note to Job Applicants** : Please be aware of scams being perpetrated through the Internet and social media platforms. Clarios will never require a job applicant to pay money as part of the application or hiring process.
    $74k-117k yearly est. 53d ago
  • Quality Systems Manager

    Rapid Resource Recruiters

    Quality manager job in Battle Creek, MI

    To provide direction and leadership for product quality and ensure that adequate resources are available to monitor/check production quality. To meet all product engineering and quality system requirements for all customers. Job Description ESSENTIAL JOB FUNCTIONS 1. Product Engineering Requirements (40 %) 1.1 Review all customer submission paperwork for accuracy, completeness and reasonableness. Assure that any required concessions or changes are incorporated. 1.2 Establish positive relationships with end customers. 1.3 Develop engineering standards for tooling and materials to ensure manufacturing capability for future programs. 2. Quality Engineering Requirements (50 %) 2.1 Establish and implement policies and procedures in compliance with QS9000 / TS 16949 requirements which will help establish operating principles, reduce quality problems and improve cost performance. Assure that policies are followed and that necessary changes are documented and implemented. 2.2 Ensure that timely feedback regarding quality concerns is provided to the appropriate individuals. Ensure that the proper functional disciplines within the plant facility and the appropriate employees are involved in problem resolution for quality issues. 3. Departmental Responsibilities (10%) 3.1 Foster an attitude of teamwork within the department and operation. 3.2 Prepare and control departmental budget. ADDITIONAL JOB FUNCTIONS 1. Monitor and direct customer-specific product/quality activities. 2. Establish departmental employees training plan. 3. Ensure that plant environmental objectives are achieved via ISO14001 compliance. 4. Additional duties as required by immediate supervisor. RELATIONSHIPS Communicates and works directly with the quality and engineering personnel, production personnel, and other staff members. SUPERVISION Works under the direct supervision of the Plant Manager. Qualifications KNOWLEDGE SKILLS/ABILITIES REQUIRED 1. Ability to make independent decisions. 2. Demonstrated leadership capabilities. 3. Thorough knowledge of Customer Quality System Requirements. 4. Demonstrated understanding of Engineering systems and standards. 5. Working knowledge of manufacturing equipment and associated finish tooling. 6. Strong oral and written communication skills. 7. Knowledge and demonstrated proficiency in various statistical techniques. 8. Working knowledge of MS Excel, Word and Project. 9. Knowledge of QS9000 compliance requirements and standards 10. Knowledge of ISO14001 requirements and standards. EDUCATION/TRAINING/CERTIFICATION/LICENSE REQUIRED Bachelors Degree required. 8 years minimum engineering or quality experience. 3 years minimum previous supervision or management experience. WORKING CONDITIONS: 1. Degree of Physical Demands (Strength) usually associated with this classification: Light work: Exerting ten (10) to fifteen (15) pounds of force infrequently. 2. Environmental Conditions (Physical Surroundings) usually associated with this classification: Incumbent is exposed to internal office conditions and infrequent exposure to internal plant conditions and loud noise(s). 3. Environmental Conditions (Hazards) usually associated with this classification: Infrequent exposure to hi-lo traffic. Additional Information All your information will be kept confidential according to EEO guidelines.
    $77k-123k yearly est. 60d+ ago
  • Quality Manager

    Grupo Antolin 4.5company rating

    Quality manager job in Howell, MI

    Howell, MI Who are we: Antolin is a leading global automotive supplier, we are experts in designing, manufacturing, and supplying innovative solutions for vehicles around the world. Our product portfolio includes trim, headliners, and acoustic systems, as well as lighting and other interior systems. We offer comprehensive solutions with a focus on quality, safety, and sustainability. Our products are used in many of the world's leading car brands, including JLR, BMW, Toyota, Volkswagen, Audi, Mercedes-Benz, and Ford. What can we offer you: You will be part of a highly engaged multinational Organization with international career opportunities. We offer you a learning journey adapted to your professional experience. You will work on international projects for world- renowned companies in Automotive sector. You can find an Open Environment to learn new technologies. We can offer you a competitive salary, benefits and valuable OEM discounts. Mission: The job mission of the Quality Manger is to ensure the quality management system is upheld and the products and processes meet customer, regulatory, and industry requirements throughout the product lifecycle. Responsibilities: Ensure compliance with IATF 16949, customer specific requirements, and applicable regulatory standards. Lead quality planning, assurance, and control activities from APQP to serial production. Drive zero defect strategy through preventative quality tools such as: FMEA, SPC, and Control Plans. Manage customer quality performance including PPAP submissions and audits. Monitor and improve supplier quality performance and development. Responsible for plant KPI's and lead continuous improvement initiatives. Direct Customer and Supplier liaisons for plant quality activities and concerns including scheduled visits. Establish and maintain all quality documents, samples, customer contact, supplier development, production start - up, product launch, and correction of production variances and warrant analysis. Manage Customer and Supplier quality scorecard and address any issues accordingly. Coordinate and lead all internal, external and Customer quality audits. What we are looking for: A Bachelor's degree in Engineering or Quality or equivalent work experience in the automotive industry with previous Management experience. 5+ years of prior Quality Management or Supervision. TS-16949 experience required. Here at Antolin, we are an equal opportunity employer and value diversity in our workplace. We do not discriminate based on race, religion, colour, national origin, gender, sexual orientation, age, marital status, or disability status. All qualified applicants will receive consideration for employment without regard to any of these protected characteristics. We encourage applications from all individuals and strongly support diversity in our workplace. We strive to create an inclusive environment for everyone, and we are committed to treating everyone in a fair and equitable manner. We are proud to be an equal opportunity employer and are committed to fostering a diverse and inclusive work environment. This is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities. The Company reserves the right to revise the job description at any time. Duties, responsibilities or activities may change, or new ones may be assigned at any time with or without notice. The employee must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations may be made to enable employees with disabilities to perform the essential functions of the job, absent undue hardship. DREAM. DARE. DO
    $74k-98k yearly est. 3d ago
  • BMS Quality Manager (BQM) - Data Center Design, Engineering and Construction

    Meta 4.8company rating

    Quality manager job in Lansing, MI

    Meta is seeking an experienced Building Management System (BMS) Quality Manager to join our Data Center Engineering & Construction (DEC) Quality team. Our team's mission is to optimize the delivery of our Building Management Systems to ensure it is completed on time, is safe, robust, reliable, and conforms to our design and quality requirements. Role will be supporting internal cross-functional teams, lead installation and commissioning efforts, oversee quality, and quickly adapt in an evolving space.Our data centers are the foundation upon which our rapidly growing infrastructure efficiently operates, and our innovative services are delivered. Building and operating data centers the "right" way is synonymous with ensuring high uptime, capacity availability and capital conservation. The data center engineering team thinks from chip to chiller (or electrical substation), determining configurations and ensuring maximum efficiency of our compute infrastructure. **Required Skills:** BMS Quality Manager (BQM) - Data Center Design, Engineering and Construction Responsibilities: 1. Manage, onboard, and lead the General Contractor BMS Lead(s), the Control Systems Integrator (CSI) and Electrical and Installation (E&I) controls contractor s throughout all phases of the project, while developing efficiency improvements and incorporating lessons learned to ensure a safe, robust, reliable and functional controls system that adheres to Meta's design and quality requirements 2. Establish a clear vision and foster cross-functional collaboration, coordination, and support among on-site project teams, including the Meta BMS team, general contractors, Control System Integrators, and installation contractors 3. Drive consistency and standardization across all buildings and Control System Integrators and installation contractors 4. Review, understand and ensure project level adherence to the issued revision of the BMS PLC Playbook 5. Perform BMS inspections (wiring, installation, and commissioning) and validate the status/progress of the projects including supporting the project teams, both internal and external, starting from the early stages of Mechanical, Electrical and Plumbing (MEP) construction by working with project level Construction Managers (both internal and external) to check the health of the project (including schedule), working with the project teams and supporting Regional Quality Managers (RQMs). Align internally on program/project related communications to ensure a clear, consistent message to trade partners 6. Assess team performance, build relationships and to support the project benchmark and mock-up process of the BMS installations to assure consistency across the project while coordinating these efforts across multiple cross-functional partners, in a timely manner, to minimize re-work 7. Work with Construction Managers, Regional Quality Managers and General Contractors to ensure creation, accuracy and maintenance of logical schedule(s) for construction, commissioning, and packaged equipment BMS activities while leveraging this data to identify early finish dates for detailed design delivery 8. Coordinate and manage both packaged equipment factory installed controls audits and BMS commissioning audits to ensure specification/requirement adherence and track identified deficiencies through completion 9. Coordinate and lead large multi-stakeholder meetings on a regular basis and communicate discussions to all key stakeholders 10. Support custom tooling and their integration into the construction processes as well as supporting other cross-functional program/project initiatives that directly impact the delivery of the BMS while simultaneously working to identify and mitigate risk associated with these efforts 11. Travel domestically as needed (anticipated 40-50% travel) **Minimum Qualifications:** Minimum Qualifications: 12. Bachelor's degree (Engineering, Construction Management, or equivalent degree) or relevant work experience 13. 10+ years of experience with a combination of Instrumentation and Controls programming/installation, general contractor MEP coordination/project management, commissioning (both mechanical and electrical) of data centers, or other large scale mission critical buildings 14. Experience with Industrial Automation and Building Management Control Systems (i.e. PLC/DDC) 15. 3+ years of experience with programming/designing of HVAC control systems & Electrical Power Monitoring **Preferred Qualifications:** Preferred Qualifications: 16. Experience with PLC, SCADA and OPC UA systems 17. Experience with Schneider Electric Unity Pro, AVEVA, and Ignition platforms 18. Experience with Schneider Modicon and Rockwell Allen-Bradley PLC Platforms 19. Experience with Autodesk ACC Build and Procore Platforms 20. Certified in the following: cGMP, CAP (Certified Automation Professional), and/or PMP (Project Management Professional) **Public Compensation:** $150,000/year to $209,000/year + bonus + equity + benefits **Industry:** Internet **Equal Opportunity:** Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment. Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at accommodations-ext@fb.com.
    $150k-209k yearly 29d ago
  • Senior Quality Assurance Specialist

    Niowave 3.5company rating

    Quality manager job in Lansing, MI

    Summary/Objective The Senior Quality Assurance Specialist is responsible for the effective, efficient, compliant and proactive management of new product launches and sustaining existing products. Senior level roles are considered subject matter experts and have the additional responsibility to coach and mentor additional team members in enhancing their technical knowledge and application of skill. Senior level positions also have the expectation of developing and enhancing their own coaching, mentoring, and soft (human) skills to fulfill their roles. Essential Functions Uses quality tools to track and trend products and processes to internal and external metrics, regulatory standards and implement improvements. Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards. Lead and/or support Internal and External Audits. Support training management for quality and operations personnel. Acts as a customer liaison and processes customer quality complaints. Lead and manage quality involvement for the development of new products or sustaining products via validation methodologies such as TMV, equipment, process and product. Support DMF submissions and IND submissions with the regulatory bodies and customers as needed. Assist the development of essential QS deliverables including, but not limited to complaint analysis, risk analysis, failure mode and effects analysis, nonconformances, CAPA, Complaints and process/equipment/software verification/validation. Lead or guide team on NCMR, Complaints and CAPA. Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations and improve productivity. Participates in pre- and post-production reviews and approvals providing quality and regulatory support. Works with cross-functional teams to solve production and quality problems. Lead quality and compliance by complying with all Quality Systems documentation requirements and establishing/supporting plan(s) to meet/exceed Niowave goals for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives. Lead and develop team members to develop our best team. Ensure the growth of our positive business culture through behaviors that align with our values and leadership competencies. Competencies Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams. Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understands their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two. Knowledge of 21 CFR Part 211/212 and ICH Q7-Q12 is preferred Ability to apply logic and reasoning to solve complex problems, including identifying strengths/weaknesses, locating alternative solutions and conclusions, and approaches to problems; and making high-quality, timely decisions. Knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization. Utilizes process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, test method validation, and trend analysis techniques. Knowledge of pharmaceutical quality requirements for launching and sustaining new products, such as Lifecycle Management, Quality by Design or Technology Transfer. Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities. Experience with and working knowledge of cGMP and GLP quality systems. Knowledge of procedures and tools for scheduling and controlling production runs and assuring quality deliverables E.g., MRP, ERP systems. Required Education and Experience Bachelor's degree in Sciences or Engineering 5+ years of relevant quality system experience in pharmaceuticals. Preferred Education and Experience Masters degree in Sciences or Engineering Quality or Regulatory certifications are preferred (e.g., CQE, CQA, CQM, RAC) 8+ years of relevant quality system experience in pharmaceuticals. Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S) Experience operating in a cGMP CDMO or Finished Drug environment. Physical Demands The position operates in a professional office and industrial environments which includes the use of standard office equipment and/or machinery related to the production of medical isotopes. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to (20 - 50) pounds. Position Type/Expected Hours of Work/Travel Full-time position. Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to work outside of the standards operating hours as needed. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. Other duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
    $73k-95k yearly est. 60d+ ago
  • Quality Supervisor-2nd Shift

    Autokiniton

    Quality manager job in Belleville, MI

    2nd Shift-Quality Supervisor We are AUTOKINITON (pronounced auto-ken-i-TAHN) AUTOKINITON delivers operational excellence, high-quality execution, and customer service. We offer 100% vertical integration capabilities such as end-to-end engineering, manufacturing, and in-house logistics. We're proud of our Tier 1 supplier legacy for manufacturing propulsion-agnostic, structural automotive components, and assemblies around the globe. To help us drive excellence, you'll get to: * Interprets specifications and job orders to workers and assigns duties. * Ensures effective utilization of manpower to minimize overtime requirements. * Studies production schedules and estimates worker hour requirements for completion of job assignment. * Ensures daily communication of relevant events is completed daily from shift to shift. * Maintains production, quality and timekeeping reports and records accurately. * Examines products for adherence to specification and processes for adherence to standards. * Directs and leads CI improvement projects/meetings. * Direct, lead, and maintain the team's 5S excellence and adherence. * Ability to communicate with large groups (present in department meetings, training, plantwide, etc.). * Continue the growth and learning process of his/her team members through sharing knowledge and best practices. * Directs all NCF products and schedule to make parts useable. * Maintains a high level of confidentiality in all duties. * Addresses and follows through on Quality concerns and Corrective Actions. * Revises all applicable APQP documentation. * Develop and incorporate proper on going SPC. * Assist Staff Quality Engineers, Senior Quality Engineers, and Quality Manager. * Improves and maintains current Quality systems. * Understands basic quality principles. * Produces sample submissions involving initial samples engineering change prototypes and pilots. * Perform internal and external Quality system audits. * Produces sample submissions involving initial samples, engineering changes, prototypes, and pilots. * Schedules and conducts meetings with customers, suppliers, in plant personnel and facilities distribution of minutes. * Generates and updates customer specific Quality documentation. * Organize the procurement, design development, qualification, and documentation of gauging. This full-time Salary role is a part of our Belleville Plant 2 team and reports to the Quality Manager. Required experience: * Bachelor's degree (B. A.) from four-year college or university; or two-five years plus related experience and/or training; or equivalent combination of education and experience. * Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization. * Microsoft Office at an intermediate level * Microsoft Project at a beginning level * Effective email and electronic communication skills are required. Working conditions: * We'll provide position-specific details including physical and focused efforts, working environment and conditions, and reasonable accommodations during the interview process. Where you'll be: This position is located at our Belleville Plant 2 in Belleville, MI offering many community events, resources, programs, and recreational opportunities for you and your family. Community features: * Lakes and Parks * Restaurants and Dining * Close to highways (I-94 and I-275) Why you'll enjoy working here: * Competitive Wages and Comprehensive Benefits: Medical, Dental, Vision, 401(k) with Company contribution match, and 14 paid holidays, including a bridge holiday in December. * Work-Life Balance: Many of our Associates have stayed with us for 25+ years! It takes a good work-life balance to make it that far. We support your personal and professional priorities as they impact your well-being. * Growth Opportunities: Take your career to the next level through tuition reimbursement programs, on-the-job training, learning management systems, and advancement opportunities from within our organization. * Learning and Development: We empower all our Associates - from entry-level to senior-level - with the skills and knowledge necessary to succeed in their current roles and beyond at AUTOKINITON. AUTOKINITON Promotes a dynamic and collaborative work environment for everyone. AUTOKINITON is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. AUTOKINITON makes hiring decisions based solely on qualifications, merit, and business needs at the time. Posted Date 1/7/2026
    $48k-75k yearly est. 10d ago
  • Labs Quality Systems Professional I

    Metallus

    Quality manager job in Canton, MI

    Joining the Metallus team means becoming part of a legacy that dates back over a century. We are an industry leader, manufacturing the cleanest steel in the world for companies in the industrial, aerospace and defense, automotive, and energy markets. Relocation will not be offered for this position. Purpose This role uses comprehensive knowledge of Gambrinus Metallurgical Lab testing methods to support sample testing, final metallurgical review, and the release and certification of customer orders. Responsibilities include assembling and verifying test data for compliance, as well as supporting or managing quality systems activities. The position interacts regularly with corporate quality teams, metallurgical quality assurance, external auditors, and third-party vendors. This position will also be the fill-in-supervisor to cover periodically for vacations, holidays, and/or weekends. The metallurgical lab supervisor is responsible for in process, final approval, and timely metallurgical release of customer orders for the business. Responsibilities * Interpret customer testing requirements, ensure all laboratory testing meets industry and customer specifications, identify non-conforming results, and manage the metallurgical release of products using business and data systems (LIMS, certification systems, thermal treat databases, intranet tools). * Prepare accurate metallurgical certifications by reviewing heat and product test data, confirming compliance, and incorporating customer requirements prior to shipment. * Collect, compile, measure, summarize, record, and report metallographic technical data. Familiarize and understand industry and customer technical specifications for standard nonmetallic inclusion ratings, different kinds of grain size, microstructure types, and decarburization. * Recognize and report out of tolerance conditions. Reports of sample test results and their conformance to technical specification must be complete and accurate to facilitate the metallurgical release of associated orders. * Coordinate outsourced testing when internal capacity is limited, including communicating with external labs, obtaining quotes, submitting purchase requests, and managing sample logistics. * Support and maintain quality systems in alignment with internal and external standards (ASTM, ASM, ISO17025, ISO9001), including updating procedures, maintaining training records, scheduling maintenance and calibrations, and participating in audits. * Identify and lead continuous improvement opportunities to enhance safety, accuracy, testing capabilities, productivity, cost efficiency, and support capital and CI projects across the lab. Technical Skills * Quick learner with strong initiative and process improvement mindset * Proficient in Microsoft Office for data analysis, documentation, and reporting * Effective communicator with strong verbal, written, and interpersonal skills * Detail oriented with accurate record keeping and data analysis abilities * Familiar with OSHA and EPA regulations * Strong project management skills, including prioritization, time management, and decision making * Technical knowledge of steel manufacturing, metallurgical testing, and related quality control concepts preferred Minimum Qualifications * High school diploma or equivalent with 5 years of experience in quality documentation, statistical analysis, manufacturing, laboratory work, or related. Preferred Qualifications * Associate degree's in a technical or related field with 2 years of experience in quality documentation, statistical analysis, manufacturing, laboratory work, or related. * Bachelor degree's in a technical or related field with experience in quality documentation, statistical analysis, manufacturing, laboratory work, or related preferred. The company prohibits harassment or discrimination against any employee on the basis of any status protected by law, including, but not limited to, race, religion, color, national origin, ancestry, age, disability, genetic information, gender, sex or veteran status.
    $71k-95k yearly est. 1d ago
  • Supplier Quality Engineer

    V&J Technologies 3.9company rating

    Quality manager job in Marshall, MI

    About Us Contemporary Amperex Technology Kentucky (CATK) is the US battery manufacturing subsidiary of Contemporary Amperex Technology Co., Limited (CATL). CATL is a global leader in research, development and manufacturing of battery energy storage system for vehicles, grid scale, and maritime applications. In 2024, CATL accounts for over 37% of global EV battery installed capacity. CATL has been the largest battery manufacturer in the world for the last 7 years. The Company is committed to providing cutting-edge solutions for global new energy applications. Our Vision Strive to be a global premier innovative technology corporation, deliver excellent contribution to green energy resolution for mankind, and provide a platform of pursuing the spiritual and material well-being for employees! Job Overview: To better serve the global auto industry electric vehicle trend in the United States, CATL, through its U.S.-based subsidiary, CATK, is looking for multiple highly skilled Supplier Quality Engineers to oversee quality control on the production line and to work closely with the suppliers. This role involves coordinating with suppliers, managing quality issues, and ensuring that all products meet our stringent quality standards. Essential Functions Problem Coordination on Production Site: · Oversee and coordinate the resolution of quality problems on the production site for new materials and structural parts. On-Site Quality Interface: · Act as the primary on-site interface for addressing material quality problems. · Develop and implement plans to handle poor incoming materials, considering factors like manufacturing processes and customer complaints. · Work closely with suppliers to complete cause analysis, implement corrective measures, and verify effectiveness on schedule. Containment Plan Development: · Participate in creating and implementing containment plans to manage non-conforming materials and ensure production continuity. APQP and PPAP Management: · Engage in the Advanced Product Quality Planning (APQP) process to identify and manage risks and problems during part development. · Participate in the Production Part Approval Process (PPAP) to ensure parts meet all quality and performance requirements before mass production. Customer Audit Support: · Assist relevant departments in preparing for and completing customer audits. · Ensure all quality standards and customer requirements are met during audits. SQE Team Training: · Responsible for training the Supplier Quality Engineering (SQE) team on quality standards, procedures, and best practices for structural parts. · Ensure the team is well-equipped to manage supplier quality issues and maintain high standards. Minimum Qualifications: · Bachelors degree in Quality Management, Engineering, or a related field. · 3+ years of experience in supplier quality control, particularly in the vehicle manufacturing industry. · Familiar with ISO9000, TS16949, and VDA quality systems. · Proficient in using quality analysis and improvement tools such as FMEA (Failure Modes and Effects Analysis), FTA (Fault Tree Analysis), 8D (8 Disciplines Problem Solving), Six Sigma, and SPC (Statistical Process Control). · Strong data analysis and processing abilities. · Proficient in using office software (e.g., Microsoft Office Suite). · Strong problem-solving skills and attention to detail. · Excellent communication and interpersonal skills. · Ability to maintain a full-time work schedule with regular in-person attendance is required for this position. · Ability to interact professionally with individuals of varied backgrounds and skill level. · Strong bilingual communication skills in Chinese and English, with the ability to effectively collaborate with Chinese suppliers and report to central teams. Physical Requirements: Ability to move around work sites, which may include walking, standing, and climbing ladders or stairs. Flexibility to bend, kneel, or crouch, particularly when inspecting installations or troubleshooting. Capability to lift and carry moderate weights, typically up to 25-50 pounds. Occasional lifting of heavier items may be required. Ability to work in various environments, including offices, construction sites, and manufacturing facilities. Willingness and ability to travel to various job sites, which may require driving or other forms of transportation Benefits: Competitive salary commensurate with experience. Comprehensive benefits package including medical, dental, and vision coverage. 401(k) retirement savings plan with company match. Paid time off and holidays. Professional development opportunities.
    $73k-92k yearly est. 60d+ ago
  • Advance Quality Manager

    Clarios

    Quality manager job in Plymouth, MI

    What you will do * Provide quality leadership across the US organization in Advanced Quality Planning (AQP) management. * Ensure product quality and compliance throughout the development lifecycle, from prototype to ramp-up. * Deploy industry and customer-specific AQP standards and integrate ASPICE processes into automotive software development. * Lead quality planning for New Product Introductions (NPIs), including risk assessments, control plans, and validation protocols. * Drive issue resolution in design validation and manufacturing processes, reducing launch risks and Cost of Poor Quality (COPQ). How you will do it * Implement APQP, PPAP, and Core Tools to align quality strategies with lifecycle stages. * Utilize JAMA for requirements traceability and Jira for issue tracking and project management. * Review, challenge, and simplify test systems while applying quality-driven procedures. * Provide technical expertise in PFMEA, Control Plans, and Inspection Standards to mitigate risks. * Facilitate structured root cause analysis and coach cross-functional problem-solving teams. * Train and mentor team members on APQP procedures, Core Tools, and best practices. * Collaborate with internal and external stakeholders to ensure successful product launches and customer satisfaction. * Document and manage lessons learned to continuously improve processes and reduce COPQ. * Conduct all activities in compliance with company safety policies and procedures. What we look for Required * Bachelor's degree in Electrical Engineering, Chemical Engineering, Quality Management, or related field. * Minimum 5+ years of experience in quality management within automotive, electronics, or manufacturing industries. * Proven experience with APQP, PPAP, Core Tools, ASPICE implementation, and software quality processes. * Strong leadership and coaching abilities with excellent problem-solving and analytical skills. * Proficiency in quality methodologies (FMEA, SPC, MSA). * Experience with JAMA and Jira for requirements and issue management. * Effective communication and stakeholder management skills. Preferred * Master's degree in engineering or quality management. * Six Sigma Green/Black Belt certification. * ISO 9001/IATF 16949 auditor certifications. * ISO 26262 certification. * CQE (Certified Quality Engineer) certification. * Familiarity with AIAG/VDA Core Tools. This position is not eligible for sponsorship. #LI-SG1 What you get: * Medical, dental and vision care coverage and a 401(k) savings plan with company matching - all starting on date of hire * Tuition reimbursement, perks, and discounts * Parental and caregiver leave programs * All the usual benefits such as paid time off, flexible spending, short-and long-term disability, basic life insurance, business travel insurance, Employee Assistance Program, and domestic partner benefits * Global market strength and worldwide market share leadership * HQ location earns LEED certification for sustainability plus a full-service cafeteria and workout facility * Clarios has been recognized as one of 2025's Most Ethical Companies by Ethisphere. This prestigious recognition marks the third consecutive year Clarios has received this distinction. Who we are: Clarios is the force behind the world's most recognizable car battery brands, powering vehicles from leading automakers like Ford, General Motors, Toyota, Honda, and Nissan. With 18,000 employees worldwide, we develop, manufacture, and distribute energy storage solutions while recovering, recycling, and reusing up to 99% of battery materials-setting the standard for sustainability in our industry. At Clarios, we're not just making batteries; we're shaping the future of sustainable transportation. Join our mission to innovate, push boundaries, and make a real impact. Discover your potential at Clarios-where your power meets endless possibilities. Veterans/Military Spouses: We value the leadership, adaptability, and technical expertise developed through military service. At Clarios, those capabilities thrive in an environment built on grit, ingenuity, and passion-where you can grow your career while helping to power progress worldwide. All qualified applicants will be considered without regard to protected characteristics. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please apply. Diversity of experience and skills combined with passion is key to challenging the status quo. Therefore, we encourage people from all backgrounds to apply to our positions. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran or other protected characteristics protected by law. As a federal contractor, we are committed to not discriminating against any applicant or employee based on these protected statuses. We will also take affirmative action to ensure equal employment opportunities. Please let us know if you require accommodations during the interview process by emailing Special.Accommodations@Clarios.com. We are an Equal Opportunity Employer and value diversity in our teams in terms of work experience, area of expertise, and all characteristics protected by laws in the countries where we operate. For more information on our commitment to sustainability, diversity, and equal opportunity, please read our latest report. We want you to know your rights because EEO is the law. A Note to Job Applicants: please be aware of scams being perpetrated through the Internet and social media platforms. Clarios will never require a job applicant to pay money as part of the application or hiring process. To all recruitment agencies: Clarios does not accept unsolicited agency resumes/CVs. Please do not forward resumes/CVs to our careers email addresses, Clarios employees or any other company location. Clarios is not responsible for any fees related to unsolicited resumes/CVs.
    $74k-117k yearly est. Auto-Apply 51d ago
  • Quality Systems Manager

    Rapid Resource Recruiters

    Quality manager job in Battle Creek, MI

    To provide direction and leadership for product quality and ensure that adequate resources are available to monitor/check production quality. To meet all product engineering and quality system requirements for all customers. Job Description ESSENTIAL JOB FUNCTIONS 1. Product Engineering Requirements (40 %) 1.1 Review all customer submission paperwork for accuracy, completeness and reasonableness. Assure that any required concessions or changes are incorporated. 1.2 Establish positive relationships with end customers. 1.3 Develop engineering standards for tooling and materials to ensure manufacturing capability for future programs. 2. Quality Engineering Requirements (50 %) 2.1 Establish and implement policies and procedures in compliance with QS9000 / TS 16949 requirements which will help establish operating principles, reduce quality problems and improve cost performance. Assure that policies are followed and that necessary changes are documented and implemented. 2.2 Ensure that timely feedback regarding quality concerns is provided to the appropriate individuals. Ensure that the proper functional disciplines within the plant facility and the appropriate employees are involved in problem resolution for quality issues. 3. Departmental Responsibilities (10%) 3.1 Foster an attitude of teamwork within the department and operation. 3.2 Prepare and control departmental budget. ADDITIONAL JOB FUNCTIONS 1. Monitor and direct customer-specific product/quality activities. 2. Establish departmental employees training plan. 3. Ensure that plant environmental objectives are achieved via ISO14001 compliance. 4. Additional duties as required by immediate supervisor. RELATIONSHIPS Communicates and works directly with the quality and engineering personnel, production personnel, and other staff members. SUPERVISION Works under the direct supervision of the Plant Manager. Qualifications KNOWLEDGE SKILLS/ABILITIES REQUIRED 1. Ability to make independent decisions. 2. Demonstrated leadership capabilities. 3. Thorough knowledge of Customer Quality System Requirements. 4. Demonstrated understanding of Engineering systems and standards. 5. Working knowledge of manufacturing equipment and associated finish tooling. 6. Strong oral and written communication skills. 7. Knowledge and demonstrated proficiency in various statistical techniques. 8. Working knowledge of MS Excel, Word and Project. 9. Knowledge of QS9000 compliance requirements and standards 10. Knowledge of ISO14001 requirements and standards. EDUCATION/TRAINING/CERTIFICATION/LICENSE REQUIRED Bachelors Degree required. 8 years minimum engineering or quality experience. 3 years minimum previous supervision or management experience. WORKING CONDITIONS: 1. Degree of Physical Demands (Strength) usually associated with this classification: Light work: Exerting ten (10) to fifteen (15) pounds of force infrequently. 2. Environmental Conditions (Physical Surroundings) usually associated with this classification: Incumbent is exposed to internal office conditions and infrequent exposure to internal plant conditions and loud noise(s). 3. Environmental Conditions (Hazards) usually associated with this classification: Infrequent exposure to hi-lo traffic. Additional Information All your information will be kept confidential according to EEO guidelines.
    $77k-123k yearly est. 10h ago
  • Manager, Global Product Quality - Controlled Substances

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Quality manager job in Lansing, MI

    The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $104.6k yearly 33d ago
  • Senior Quality Assurance Specialist

    Niowave 3.5company rating

    Quality manager job in Lansing, MI

    Senior Quality Assurance Specialist Who we are… We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living. Who you are… You have a precise nature and embrace attention to detail. You value established procedures to ensure first-time quality for accurate and on-time results. Words that describe you are consistent, efficient, diligent and technologically savvy. You also embrace change to keep pace with emerging information and shifting priorities, offering suggestions to improve process flows. You get great satisfaction from launching new products, improving compliance on existing products or procedures and rise to the occasion to take on miscellaneous projects. You easily transition between working independently to working with a team with excellent customer service as your internal guide. What you will achieve… Lead or guide team on NCMR, Complaints and CAPA; lead and/or support Internal and External Audits. Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations and improve productivity. Participates in pre- and post-production reviews and approvals providing quality and regulatory support. Lead quality and compliance by complying with all Quality Systems documentation requirements and establishing/supporting plan(s) to meet/exceed Niowave goals for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives. Lead and develop team members to develop our best team. Ensure the growth of our positive business culture through behaviors that align with our values and leadership competencies. Support training management for quality and operations personnel. Acts as a customer liaison and processes customer quality complaints. Lead and manage quality involvement for the development of new products or sustaining products via validation methodologies such as TMV, equipment, process and product. What you need to succeed… Bachelor's degree or equivalent in STEM field 8+ years of relevant experience in the pharmaceutical industry with direct experience with compliance and quality systems. Knowledge of pharmaceutical quality requirements for launching and sustaining new products, such as Lifecycle Management, Quality by Design or Technology Transfer. Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities. Experience with and working knowledge of cGMP and GLP quality systems. Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understands your own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two. Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams. Great to have… Masters degree in STEM field Quality or Regulatory certifications are preferred (e.g., CQE, CQA, CQM, RAC) 10+ years of relevant experience in the pharmaceutical industry with direct experience with compliance and quality systems. Hands-on experience utilizing lean manufacturing principles for continuous process improvements (Six Sigma, Lean Manufacturing, 5S) Experience operating in a cGMP CDMO or Finished Drug environment. Work Environment The company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to work outside of the standard operating hours as needed. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. Please provide a cover letter specifically describing the nature of your technical expertise.
    $73k-95k yearly est. 60d+ ago

Learn more about quality manager jobs

How much does a quality manager earn in Jackson, MI?

The average quality manager in Jackson, MI earns between $59,000 and $142,000 annually. This compares to the national average quality manager range of $64,000 to $128,000.

Average quality manager salary in Jackson, MI

$92,000
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