Quality assurance manager jobs in Battle Creek, 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 (**************************************** .

Summary/objective The Engineering and Facilities (E&F) Planning Coordinator works closely with project team members, members of the leadership team and key customers to help deliver major organizational projects and key initiatives efficiently. The E&F Planning Coordinator manages the technical and administrative tasks, such as scheduling, resource forecasting and planning, document and information distribution, report collation and communication support. The E&F Planning Coordinator, Engineering/Facilities provides direct support to the Facilities and Engineering Team. This position is integral to the successful coordination, alignment, and management between the departments/disciplines related to engineering, design, fabrication, building operations (facilities), EH&S, radiation safety and cGMP quality regulations. You are an open minded, committed team player who is able to meet people where they are and utilize communication and tools to masterfully guide them to the goal. Words used to describe you include self-starter, resilient, exhibits patience and grace. You are energized by completing tasks well and on time, enabling teams to reach optimal outcomes. You are someone who lives and breathes keeping things organized and supporting others in being successful. Essential functions Work independently and with members primarily in or related to the engineering/facilities, accelerator, EH&S, radiation safety including but not limited to project leads within the technical teams, and members in the leadership team.. Maintain portfolio of medium complexity projects supporting manufacturing and continuous improvement. Development of templates and standards for electronic project tracking and resource estimation. Masterfully manage up, down, and across the organization to optimize outcomes and proactively contribute to a fun, nurturing, motivating culture. Provide information and regular support to stakeholders. Serve as point of contact for various working groups; Share relevant documentation and reports with project teams. Develop in-depth understanding of project scope and particulars i.e. timeframes, project teams, etc. Schedule project activities for internal team and contractors. Maintain senior leadership and execution level schedules for project success. Understand formal escalation and review processes. Provide support to project managers and business leaders. Thorough project documentation; Creating and reviewing of reports. Positively influence a diverse team of skilled professionals. Within the department and across the organization, foster a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization. Competencies Excellent communication and interpersonal skills - you know how to develop & maintain strong relationships with all levels/teams of the organization. Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understand how to integrate into a new team/organization - appreciate 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. Understand your own communication and learning styles, assess others' styles, and are able to find the right path to connect the two. Exceptional technology skills - you find working with any software very comfortable and you easily adapt to new products; Highly efficient with MS Office products; Expert skill with project tracking such as MS Project and Smartsheet is essential. Extremely attentive to details, particularly with written communications, and PowerPoint presentations. Highly responsive and resourceful. Ability to anticipate needs and use good business judgment in escalating priority issues. Extremely confidential; experienced in handling highly sensitive information discreetly. Accountable, responsible, and able to work independently. Very flexible, able to pivot quickly as priorities change. Professional demeanor; calm, polite, kind, well-spoken. Required education and experience Bachelor's degree in engineering, business, management, or related field or equivalent combination of work experience, certifications and/or degree. 8+ years' experience supporting project teams and providing technical and administrative support to others. Preferred education and experience Formal training/experience in agile project management. Formal training/experience with Scrum and Lean project management framework and tools. Project management certification such as CAPM, PMP, PMI-ACP, or CSM. MS Office certification. Educational or work experience with manufacturing, engineering, information systems. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment. Physical Demands 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 occasionally required to: Stand; walk; sit; stand and sit for prolonged periods Use hands and fingers to handle, or feel objects, tools or controls Vision abilities including near vision/acuity and visual color discrimination Talk and hear Reach with hands and arms Climb stairs Wear safety glasses, goggles, gloves, and Tyvek suit Ability to lift or move products and supplies, up to 25 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 is a part of shift work including nights, weekends, and holidays. 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.

Baking a Better Future "Our team is like a good recipe. All the ingredients come together to make an incredible product." Champion Foods, a pizza trailblazer, is expanding, and we're looking for dynamic talents to enhance our innovative and quality-driven team. We produce products cherished by families nationwide and pride ourselves on our entrepreneurial spirit, commitment to quality, and a warm workplace culture that feels like family. If you're passionate, eager to grow, and want to work for a company that values each voice and champions personal development, your next career adventure starts here. Join us, and let's craft great things together, one delicious slice at a time. Your Mission: You will lead and manage the quality assurance programs, policies, and initiatives for our company's products. Additionally, you will be responsible for developing inspection, testing, and quality control procedures, designing quality training programs, investigating customer complaint issues, and facilitating quality audits. You will have the opportunity to lead our quality assurance staff, including training food technologists in the lab procedures and auditing techniques. What You'll Do: Create and implement updated policies, procedures, and programs that ensure product safety and quality, including updating product specifications and issuing changes. Identifies and resolves supplier food safety and quality issues. Provides technical support and acts in a liaison role with the quality control function to develop and ensure controls are developed, executed, and maintained. Manages critical food lines and implements new laboratory procedures and instrumentation, and assists the international department with manufacturing and problem resolution. Communicates with staff, other departments, and suppliers with product specifications and program changes as appropriate. Responsible for direct involvement in corporate product recalls and retrievals if required, and maintains appropriate documentation. Administers mock recalls to distribution centers. Coordinates samples from distribution centers, sanitation audits, and lab testing. Lead quality assurance staff, including coaching, development, and required training. Assists leadership in policy creation for vendors, vendor evaluation, and audits Maintains approved manufacturer list for regional vendors. Performs other duties as requested by Supervisor. Responsible for management of others, including hiring and performance management. What You'll Bring: Bachelor's degree in food science, Biology, Chemistry, or related discipline. Minimum of five (5) years quality assurance experience in the food industry and a total of seven (7) years' total quality assurance experience. Knowledge of the food industry manufacturing practices and familiar with governmental regulations. (Exclusively for Domestic: including OSHA lab standards and Good Manufacturing Practices as defined by the FDA.) Ability to communicate effectively with vendors and other departments, often communicating complex technical data to a variety of audiences. Evidence of the ability to establish, document, update, and track quality metrics, preferably through standardized and accepted process control procedures. Experience in a previous position requiring accuracy, attention to detail, and documentation of issues, resolutions, and policy changes. Excellent problem-solving and decision-making skills. Good interpersonal skills and ability to resolve conflicting points of view. Demonstrated ability to manage multiple, complex projects and initiatives simultaneously with a results-oriented approach. Computer proficiency (Microsoft Office, database, Internet, and documentation software required. Ability to travel up to 20% of the time and to adhere to the company's corporate travel policy. HACCP certification and foodservice sanitation certification. Experience with lab analysis and testing on products used in the pizza business. Sensory abilities for product evaluation. Where You'll Work: Ability to travel domestically 20% of the time and adhere to company travel policies. Exposure to travel elements, plant environments, spice odors, higher or lower than average temperatures. All items listed above are illustrative and not comprehensive. They are not contractual in nature and are subject to change at the discretion of Champion Foods LLC. Champion Foods LLC is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regards to that individual's race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender identity, age, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law. The Company will strive to provide reasonable accommodations to permit qualified applicants who have a need for an accommodation to participate in the hiring process (e.g., accommodations for a job interview) if so requested. This company participates in E-Verify. Click on any of the links below to view or print the full poster. E-Verify and Right to Work.

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Job Description We are looking for IVR QA Analyst & IVR Test Lead in Dimondale, MI Qualifications Position 1: The IVR Test Lead will lead a team of 2 - 3 people in utilizing Testing Center of Excellence (TCoE) processes, frameworks, templates & tools to perform all tasks within the Software Testing Life Cycle, including analyzing requirements, creating test scenarios, conditions and scripts, creating and managing test data, performing test execution and managing defect management processes. The IVR Test Lead is responsible for ensuring on time and on budget completion of all scheduled tasks and that all test artifacts for the project meet strenuous standards. Additionally, the IVR Test Lead will lead the implementation and utilization of web service test tools. Position 2: The IVR Test Analyst will align with the process & frameworks and leverage templates & tools to perform all aspects of the Software Testing Life Cycle, including analyzing requirements, creating test cases, conditions and scripts, creating and managing test data, test execution and defect management processes. The Test Analyst is responsible for ensuring on time and on budget completion of all scheduled tasks and that all test artifacts meet strenuous standards Additional Information Webcam interview is acceptable.

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

Job Description Grand Design RV is currently looking for a Line Quality Manager . As a Grand Design team member in this role, you will be responsible for ensuring Grand Design RV's Product quality through inspection and reporting quality attributes along with improving performance by working with manufacturing to discover root causes and applying corrective actions. Our Story Founded in 2012, Grand Design has become one of the fastest-growing RV brands in history and is consistently rated among the highest quality RV manufacturers in North America. Case in point? August 2023 was cause for celebration after Grand Design produced its 250,000th recreational vehicle. "Reaching this mark is not just a testament to the hard work and vision of our incredible team, but it is also a reflection of the trust and loyalty our customers have placed in us," (Don Clark, President and CEO). "We strive for nothing less than customers for life." As our journey continues, Grand Design remains focused on its mission: to lead the industry in quality and innovation, while fostering a family-like connection among our team members, customers, and dealers. That's our story and our journey. What's yours? If you like working in a fast-paced environment, connect with purpose, execute with excellence, and are ready to transform the road ahead, we welcome you to begin your journey by applying today! Key Areas of Responsibility Monitors performance of quality control systems to ensure effectiveness and efficiency. Implement processes designed to identify, correct, and eliminate product defects (test, inspection, RCCA/8D, work design, etc.). Understand and apply standard operating procedures and quality assurance manuals. Lead, supervise, and support online quality control inspectors, systems testers, and electrical inspectors. Maintain correct staffing levels for production inspection. Regularly participate in product audits, staff meetings, and product development meetings. Work closely and collaborate with plant managers, product managers, group leaders, line workers, codes and compliance, testing auditors, and offline PDI teams to ensure objectives are effective and met. Understand and execute quality performance reporting tools. Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends. Communicate with supply chain team on vendor supplied/issues. People Development Education & Experience BS Degree with 5+ years of related work experience preferred. Leadership/Management experience required, minimum of 2+ years. Electrical, Plumbing, and LP equipment experience. Strong analytical and problem-solving skills (8D, A3, 5Ys, etc.) preferred. Strong verbal and written communication skills. Microsoft Office Suite (Excel, Outlook, Word, PowerPoint) required. RV Industry or commercial vehicle knowledge or background preferred. Physical Demands Will be out on the production floor 70-90% of the time. May need to lift, push, pull, between 30-60lbs. On occasion this role may be utilized to substitute in times of team member(s) absences (online QCs/testers, other managers) Some travel may be required, 5-10% of the time. Able to work early and flexible hours. Our Core Values Gratitude - Safely serving team members and our communities through humility and empathy to make our company, communities, and world a better place. Respect - Acting with integrity and transparency because believing in each other is the building block for all other relationships. Accountability - Holding each other to the highest expectations in all we say and do. iNnovation - Striving to be industry-leading with our people, processes, and products. Drive - Determined to exceed the expectations of our team members, vendors, dealers, and retail customers. At Grand Design, we believe ALL people are leaders and hold each other accountable to high expectations. Leadership Expectations: Connect with Purpose Be inclusive ; seek out different perspectives. Focus on the Customer ; put yourself in the customer's shoes. Communicate Clearly ; say what needs to be said and listen. Execute with Excellence Explore Possibilities ; ask, "What if?" and embrace new ideas. Set Direction ; prioritize, plan, and align; balance thinking and action. Drive Results ; get the right things done; work with a sense of urgency. Build the Future Transform the Road Ahead ; anticipate opportunities; seek new opportunities for continuous improvement. Navigate Change ; be agile and flexible; take on new challenges. Inspire Growth ; help each other improve; commit to personal development. If you are the right candidate for this position, as a Grand Design Team Member you will be eligible for the following benefits: Medical, Dental, Vision, Group Life Insurance, Accidental Injury, Critical Illness, Short & Long-Term Disability Health Savings Account (HSA) 401(k) with match Employee Stock Purchase Program Tuition Reimbursement Holiday and Vacation Pay Grand Design is an Equal Opportunity Employer. Job Posted by ApplicantPro

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 iYvvzjWIXO

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 1 st - 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.

Provides project support with current Good Manufacturing Practices to clinical supply packaging operations. Provides guidance on procedures and training necessary to be in complete compliance with current GMPs. Additional Information All your information will be kept confidential according to EEO guidelines.

Your passion. Your purpose. If you're here, you're looking for something more. More opportunity, more impact, more purpose. At Rehmann, each and every one of our associates plays a pivotal role in the Firm's success. When you join our team, you can count on exceptional support, encouragement, and guidance from your colleagues and from leadership. No matter where you want to go in your career, Rehmann can help you get there. Whether you're in the early stages of your professional journey or you're further down your path, we're focused on helping you achieve your goals - whatever they may be. When you join Rehmann, you are part of a culture that Puts People First and aims to help everyone reach their fullest potential. Let us show you all the ways we can Empower Your Purpose. To learn more about Rehmann, visit: ******************************** In this role, you will manage audits for our public sector clients, including cities, villages, townships, counties, public school districts, community mental health authorities, and not-for-profit entities. How You Will Make an Impact: * Building relationships internally to foster a culture of teamwork and collaboration * Providing a "wow" experience to every client * Contributing to the success of our clients' organizations * Managing significant and complex audits * Researching technical issues encountered during the audit process * Presenting audit findings to client leadership * Providing direction and new challenges to associates on your team * Teaching and developing associates allowing them to reach their goals * Mentoring associates as they navigate their career paths * Participating in activities to grow the firm and generate business with new clients * Identifying opportunities to introduce other Rehmann specialists to existing clients * Making a difference in the communities where you live and work Your Desired Skills, Experiences & Values: * 5+ years of relevant assurance experience in public accounting or industry * CPA license required * Outstanding client service and communication skills * Ability to manage multiple deadlines in a fast- paced environment * Desire to develop unique business solutions in a team-based environment * Passion for coaching others to higher levels of performance * Enthusiasm for recognizing and rewarding great work by those around you * Commitment to continuous learning and development * Out-of-the box thinking and an entrepreneurial spirit * A new perspective and new ideas allowing us to continuously improve * Unwavering integrity in all situations We Put People First in all that we do. Our associates are our greatest asset and we provide programs and benefits that encourage growth and development and align with their needs and goals. This includes benefits focused on physical and mental health, paid time off for volunteering and diversity-related activities, flexible work arrangements, and more. When you join Rehmann, you become part of a firm dedicated to helping Empower Your Purpose, whatever it may be. Rehmann is an Equal Opportunity Employer #LI-VK1

Job Description In support of the Product Field Action team, implement quality standards, ensure and execute compliance on every stage of the process. Assess potential risks, ensure compliance and give recommendations. Take responsibility for all quality control aspects of the process (intake, record documentation, destruction, internal and external customer communications). Facilitates audits and regulatory inspections. Coordinates quality trainings. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience. Hours:8:00am to 5:00pm

Dear Associate, open. Please respond if interested. Manual QA Lansing, MI 12+ Months Contract Within the Quality Assurance function, the Quality Analyst will help in implementation/enhancement of manual and regression test plans. This role is responsible for the creation, execution, and maintenance of test scripts (using HP tools set) to ensure quality standards are achieved. This position also works in collaboration with Story team/technical testers to understand how changes in the software product affects maintenance of test scripts. This role helps product implementation team in meeting the quality objectives and making continuous improvements to maximize testing coverage and reduce testing cycle time. Experience: * Proven experience in documenting various test cases using tools like HP Quality Center, Atlassian * Proven experience in manual testing for web applications (frontend and backend), Web services, various other GUI applications (Mainframe, Java, etc..) and middleware's * Proven experience in design, development and maintenance of any smoke, functional, and regression test suits to ensure application code is functioning as designed. * Experience in Agile development methodologies preferable * Experience in P&C insurance domain , Guidewire product suite will be a plus * Excellent interpersonal and team skills Best Regards, Mike Curtis Additional Information Multiple Openings

Here at UPG, our motto is “Stronger Together”! Our success continues to be driven from within, starting with our dedicated employees who operate with a sense of urgency, commitment to customers and flexibility to do what is right. Founded in 2014, UPG Enterprises, LLC is a high growth, privately held operator of world-class diversified industrial businesses. Our family of companies has been built from more than 15 acquisitions in the metals, manufacturing, distribution, and logistics segments. Approaching $1.5B in annual revenue, the UPG portfolio of companies operates across the U.S., Canada, and Mexico. Maksteel USA, LLC. is hiring a qualified Quality Manager to join our growing team. This person will provide quality control and assurance functions that ensure products conform to engineering specifications and meet customer quality requirements. They will also make suggestions for process improvements that will improve the company's efficiency at meeting the customers' requirements.  Primary Duties and Responsibilities : Train new employees on company procedures and policies, including ethics, polices and safety measures. Support Quality standard and Quality Assurance while standardizing company systems. Determine and distribute work assignments and supervise projects to ensure employees collaborate towards a common objective. Perform regular audits of departments and production lines to ensure they comply with company standards. Ensures raw materials used in product production are from qualified/approved vendors and meet internal quality testing specifications. Advises other departments about quality assurance issues that impact their realm of responsibility. Familiar with and fully support APQP, PPAP, FMEA and 8D requirements. Continuously review and improve the quality control system. Investigate customer complaints to determine root cause and implement corrective actions and provide 8D reports to customers as required. Review employee productivity and performance to ensure they meet clients' requirements or recommend improvements to meet quality standards. Working closely with Engineering, Supervising QC Staff, QC lab activities supporting production and other departments. Maintain ISO certification, SOPs, Work Instructions and Quality records. Generate monthly Quality measurable and indicator and present to management with focus to improving the quality capability. Oversee Quality Lab and measurement databases. Generate monthly reports to Management for review for continuous Improvement and drive down the cost of Quality. Perform other duties/projects as assigned. Position Requirements: BS in Material Science or Engineering or equivalent experience in a High-speed stamping operation preferably in Motor Transformer lamination industry 4+ years of Quality management experience. Lean and/or Operational Excellence experience, training, or certification Previous root cause analysis experience. Plant leadership team experience preferred Effective business/technical written and verbal communication skills. Strong organizational, strategic and planning skills. High level of accuracy and attention to detail. Experience in implementation of ISO certifications, Process FMEA and Control Plan, PPAP.  Familiar with standard quality control software to handle daily QC functions.  Deals effectively with all levels of personnel, internal and external. Maintains professional contacts with domestic and international representatives Ability to communicate information verbally and in writing in one on one and group situations, meetings and conducting presentations Computer skill MS office and standard Quality related software such as Minitab or other equivalent Quality related software.   Diversity & Inclusion Statement UPG Enterprises LLC and its Affiliates is an equal opportunity employer committed to a diverse and inclusive workforce.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Applies GMP/GLP in all areas of responsibility, as appropriate Applies the highest quality standard in all areas of responsibility Demonstrates and promotes the company vision · Regular attendance and punctuality Applies the highest quality standard in all areas of responsibility Demonstrates strong client service skills, teamwork, and collaboration Proactively plans and multitasks to maximize productivity Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration Use opportunities to contribute to continuous quality and process improvement of QA department and of the laboratories Demonstrate understanding of QAU operations and functions Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare documents Perform investigation writing and review including thorough root cause analysis and CAPA review · Perform internal audits and walk through inspections Review procedures, methods and protocols · Release analytical reports Assist in hosting client audits Provide information/entries for monthly/quarterly quality reports to management Conducts all activities in a safe and efficient manner Communicates effectively with clients and staff members Performs other duties as assigned Investigation review Stability QA for protocols Qualifications Bachelor's degree in chemistry, biology, biochemistry, or related degree concentration and some laboratory experience; previous related laboratory or QA experience Additional Information Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Portage, MI are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionQuality AssuranceLocation: Portage Michigan Shift: Pay: 1st $15.00Job SummaryAre you a motivated and detail-oriented individual looking for a new opportunity? We're seeking a Quality associate, to complete quality inspections using visual inspection and quality tools. What You'll Be DoingAs a Quality associate, your core responsibilities will include: Fast paced visual inspection. Record keeping Reporting to supervision In addition, you will also be expected to assist wherever you are needed.What We're Looking ForTo be successful in this role, you should have the following:Qualifications: High School Diploma Quality experience in plastic required. Skills: Mechanically Inclined Personable Team Player Why Join Us?This is an excellent opportunity for both short-term and long-term employment. We are committed to providing a supportive work environment and opportunities for growth.Workbox Staffing Benefits: Weekly Pay Hire-in Opportunities Comprehensive Benefits including Health, Life, and Dental Veteran-Friendly and Equal Opportunity Employer Ready to start? Apply online today and let's DO GOOD together!

Make a Difference in YOUR Career! Our vision is both simple and ambitious: to put our drinks on every table. We are the world's largest bottler for retailers and A-brands. Our products are distributed worldwide from our production sites in Europe and North America. Although our own branding may not appear on the labels of the beverages we produce, there is a good chance you are reading this while sipping one of our drinks. Our ambition is to continually improve and it's what keeps us at the top of our game. We are solutions-based. We are innovative. We seek out new challenges and conquer them. This is our company ethos, but it's our people's too: Refresco is at the cutting edge of a fast-moving industry because we have passionate people pushing the boundaries of what's best. Stop and think: how would YOU put our drinks on every table? Essential Job Functions of QA Support Tech: Adhere to all health and safety policies/procedures, Good Manufacturing Practices (GMPs) and wear the required personal protective equipment (PPE) while in the warehouse or production areas (including but not limited to hairnets/beard nets, safety glasses, hearing protection, hard toe and slip/oil resistant shoes, appropriate safety gloves, and seatbelts while operating forklifts). Responsible to adhere to food quality and food safety as per the standard(s) provided by corporate, customer, and/or governing bodies (ex. SQF). Ensure all products being run conform to the customer product specifications as outlined in SAP system, and conduct analysis on raw deliveries, finished batches and treated water. Conduct chemical and physical analysis on raw and intermediate processing materials including packaging materials and determine status of materials as acceptable or unacceptable. Evaluate finished products against current standards by performing audits to monitor all aspects of finished product and packaging integrity. Investigate all out of specification conditions and make recommendations for corrective action and document. Enter data into and confirm batches in SAP. Check process control parameters to assure proper equipment application and operation is being maintained by performing secure seal, closure torque and seaming checks. Effectively perform BBSO audits and provides feedback to the employee observed. Can send professional emails as required to provide effective communication to all levels of the organization. Understands how to generate a Process Order (COR1) and print batch sheet in emergency situations with Manager approval. Able to train coworkers up to the Tier II skill level and actively participates in the training of new techs and uses SOPs and training matrix to track progress. Knowledgeable of department KPIs and can clearly communicate continuous improvement opportunities in all QA processes. Performs Root Cause Analysis and Reporting. Stop any production which may be questionable in terms of Food Safety and immediately alert a member of the management team. Maintain accurate, legible records of all tests and retests performed. Complete all other required reports (work orders, action reports, etc.) in a timely manner. Perform analytical tests required to qualify ingredient batches for production. Perform production line checks at specified intervals. Ensure accurate test results by maintaining proper operation and calibration of laboratory equipment. Maintain laboratory cleanliness at all times. Report all out of specification results to designated leadership. Complete special projects and other reasonable duties as assigned by leadership. Has demonstrated Tier II skills have been sustained at an acceptable level with limited supervision. Required Skills: Working knowledge of Excel, Word, and SAP. Exposure to using measurement tools and equipment (e.g., calipers, micrometers, CMM machines) preferred. Organized and detail oriented, adaptable to change. Ability to apply statistical methods to analyze data and identify trends. High level of precision and accuracy in inspection and testing processes. Familiarity with ISO, Six Sigma, GMP, and other relevant standards and regulations Understanding of Food Safety Requirements. Able to read and understand metric system. Prior inspection experience in a laboratory setting. Competencies: Technical: Skilled in maintaining accurate and detailed records of inspections and tests Integrity: Commitment to maintaining high ethical standards in all quality assurance activities. Adaptability: Flexibility to adapt to changing production environments and requirements. Communication: Clear and concise communication with production staff and management Education and Experience: Highschool diploma or equivalent. 2 - 4 years of experience in Quality within a manufacturing environment. Laboratory experience required. In plants co-packaging alcoholic beverages, sensory tasting must be at least 21 years old. Working Conditions: Work Schedule: Weekdays, weekends, afternoon, evening, and overnight may be required. Overtime scheduled as needed. Work Environment: Operating in a fast-paced production plant with numerous moving parts. Noise levels require hearing protection and temperatures can get very hot and/or relatively cold (laboratory is temperature controlled). The environment is structured and supervised. Travel Requirements: 0% travel anticipated. Physical Requirements: R = Rarely (0-15%) O = Occasionally (16-45%) F = Frequently (46-100%) Physical Demand R O F Stand or Sit X Stoop, kneel, crouch, or crawl X Lifting up to 50 lbs. (minimum 5 lbs) X Carry weight, lift X Walking X Driving X Climb (stairs/ladders) or balance X Visual/Sensory: This position requires attention to detail, requiring attention with one or two senses at a time. Mental Stress: There is pronounced pressure from deadlines, production quotas, accuracy, or similar demands. Other Duties: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. A Career with Refresco Refresco offers a competitive salary and comprehensive benefits, which include: Medical/dental/vision insurance Life insurance 401(k) savings plan with company match Paid holidays and vacation Well-being benefits Discount programs Join Refresco TODAY and enjoy a rewarding CAREER! Equal Opportunity Employer Refresco is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, ancestry, religion, sex, national orientation, sexual orientation, age, marital status, disability, gender identity, gender expression, Veteran status, or any other classification protected by federal, state, or local law.

Zoetis's Veterinary Medicine Research and Development (VMRD) Product Quality group is seeking highly skilled, detail-oriented, and forward-thinking Quality Leaders who will be active members of vaccine, biopharma and pharma co-development teams providing input on co-development strategy (clinical/PK supplies, design of experiments, analytical method development and transfer, registration batch manufacture, submission planning, etc.) throughout the lifecycle of a project including transfer to Zoetis Global Manufacturing & Supply (GMS). Their goal will be to assure that long-term product sustainability is a process design deliverable by guiding co-development teams with a quality mindset. Knowledge from product and process development is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. The Quality Leaders will help to ensure that during process/product development, variation, impact of variation and control of variation is understood and well documented. The successful candidate will make sure that the appropriate level of quality and compliance is applied across all aspects of the process design stage of process validation, collaborating with both VMRD and GMS. Quality Leaders will be involved in key decision making and supportive processes of the co-development team such as risk assessments, determination of Critical Process Parameters, Critical Quality Attributes (specifications) and control strategies. The close partnership with GMS will continue across the qualification and verification phases of validation to ensure seamless transition of product quality to commercial manufacturing. The Quality Leaders will foster a culture of excellence and harmonize practices across diverse projects. They will be responsible for the review and approval of GMP documentation (batch records, protocols, reports, stability, etc.) for each project and for the maintenance and continuous improvement of the VMRD Quality Management System policies in accordance with regulatory requirements, Zoetis standards and industry best practices. Each Quality Leader will be responsible for supporting multiple projects and interfacing with partner groups in the co-development teams across the organization in both VMRD and GMS. These include global development teams, regulatory, GMS quality, formulation, chemistry, analytical, bioprocess development, PK/PD, clinical, CROs, etc. Expectation that colleague will adhere to being present on-site ≥50% of the time Responsibilities: * As part of the core co-development team, represent VMRD Product Quality through product development. Provide strategic input and participate in highly matrixed cross-functional teams with operational leaders to prioritize processes and roadmaps and drive innovation. Collaborate to develop and implement innovative solutions to improve business processes, reduce compliance risk, while driving efficiency. * Interpret and stay updated on relevant regulation and guidelines from health authorities. * Ensure that all processes, documentation, facilities, and products comply with requirements. Assure adherence to appropriate GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business lines. * Ensure a proactive and adaptive approach to evolving project needs. Champion the implementation of efficient and compliant processes. Foster a culture of quality and continuous improvement. * Use a quality-embedded mindset and practical knowledge of industry, customer requirements, and general business environment to define appropriate actions. * Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, and change control activities in the design phase * Partner with Quality Operations in GMS during the qualification and verification phases of product lifecycle to ensure a seamless approach to process transfer and to knowledge management. * Identify opportunities for automation and integrating technological solutions to simplify compliance tasks and improve quality. * Demonstrate resilience in the face of challenges, maintaining composure and guiding the team through periods of change. Basic Qualifications: * Bachelor's degree * Experience across technical (chemistry, analytical, formulation, bioprocess development, etc) disciplines with a demonstrated track-record of constructive influence on product development teams. * 10+ years pharmaceutical industry experience. Preferred Qualifications: * Masters/Graduate Degree * Quality Operations experience Strong leadership skills. * Ability to work independently at a high level. * Strong interpersonal skills and accountability in day-to-day interactions. Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Provides project support with current Good Manufacturing Practices to clinical supply packaging operations. Provides guidance on procedures and training necessary to be in complete compliance with current GMPs. Additional Information All your information will be kept confidential according to EEO guidelines.

Senior Quality Assurance Specialist - Product Quality 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.