Quality assurance manager jobs in Lansing, MI

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.

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 Quality Manager | East Lansing, MI Salary Range: $88,000 - $134,000 depending on experience Are you a dynamic leader with a passion for upholding and enhancing production standards? The Pivot Group is dedicated to building meaningful connections and supporting community growth. We are collaborating with leading companies in East Lansing seeking experienced Quality Managers to drive results. The Opportunity We are collaborating with manufacturing firms in East Lansing that are seeking skilled Quality Managers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals. Key Responsibilities Develop and implement the Quality Management System (QMS) to ensure compliance with industry standards and customer requirements. Lead root cause analysis, corrective actions (CAPA), and preventive actions for non-conformances and customer complaints. Manage all aspects of product quality control, including inspections, testing, and data analysis throughout the manufacturing process. Oversee supplier quality management, including evaluations, audits, and performance monitoring. Drive continuous improvement initiatives using methodologies like Lean, Six Sigma, and statistical process control (SPC). Lead internal and external quality audits (e.g., ISO 9001, IATF 16949) to maintain certifications and identify areas for improvement. Ensure all products meet specified quality standards, regulatory requirements, and customer expectations. Recommended Qualifications Bachelor's degree in Engineering, Manufacturing, or a related technical field. 5+ years of progressive experience in quality management within a manufacturing environment. In-depth knowledge of quality management systems (e.g., ISO 9001, IATF 16949) and quality tools (e.g., SPC, FMEA, Root Cause Analysis). Proven leadership and team management skills with a focus on continuous improvement methodologies (Lean, Six Sigma). Excellent analytical, problem-solving, and communication skills. Bonus Qualifications Lean Six Sigma Black Belt certification Experience with AS9100, IATF 16949, or ISO 13485 quality systems Proficiency in statistical analysis software (e.g., Minitab, JMP) Previous experience managing supplier quality programs Job Titles That Should Apply Quality Assurance Manager, QA Manager, Quality Control Manager, QC Manager, Director of Quality, Head of Quality, Senior Quality Manager, Quality Lead, Process Quality Manager, Operations Quality Manager, Quality Systems Manager, Continuous Improvement Manager Why Pivot Group The Pivot Group was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic-they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out. The Pivot Group offers resources to support your search-market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.

Job Details WEBBERVILLE, MI Owosso SA - Owosso, MI DayDescription The Quality Manager (QM) aims to ensure that the product or service an organization provides is fit for purpose and meets both external/internal and environmental requirements, including legal compliance and customer expectations. The quality manager coordinates the activities required to meet quality standards. The Quality manager also monitors and advises on the performance of the quality management system and produces data and reports customer performance, measuring against set indicators. The Quality manager confers with other managers and staff throughout the organization to ensure that the QA system is functioning properly. Where appropriate, the quality manager advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality. DUTIES & RESPONSIBILITIES Since maintaining quality demands adaptation to customer expectations, quality managers employ a variety of measures to place quality at the heart of an organization. These include management systems such as IATF 16949, ISO 14001, philosophies such as Total Quality Management, and methodologies such as Continuous Improvement. The work of the quality manager will be affected by the nature of the employing organization but is likely to include some or all of the following activities: · Supervise quality personnel assigned directly or indirectly to the quality department. · Promoting quality achievement and performance improvement throughout the organization; · Setting QA compliance objectives and ensuring that targets are achieved; · Committed to meeting our customers' requirements and to continually improve our process by: Supplying product that meets our customers' quality requirements, delivering the product on time to the customer, and conservatively using our natural resources · Maintaining awareness of the business context and company profitability, including budgetary control issues; · Assessing the product specifications of the company and its suppliers, and comparing with customer requirements; · Working with purchasing staff to establish and meet quality requirements per IATF 16949/ISO 14001 from external suppliers; · Ensuring compliance with national and international standards and legislation; · Considering the application of environmental and health and safety standards; · Agreeing on standards and establishing clearly defined quality methods for staff to apply; · Defining quality procedures in conjunction with operating staff; · Setting up and maintaining controls of documentation procedures for the retention period identified; · Identifying relevant IATF 16949 and quality-related training needs and delivering training; · Collating and analyzing performance data and charts against defined parameters; · Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary; · Supervising technical staff in carrying out tests and checks; · Writing technical and management systems reports; · Bringing together staff of different disciplines and driving the group to plan, formulate and agree to comprehensive quality procedures; · Persuading reluctant staff to change their way of working to incorporate quality methods; · Liaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications; · Establishing standards of service for customers or clients; · Preparing clear explanatory documents such as customers' charters; · Monitoring performance by gathering relevant data and producing statistical reports · Customer communication to resolve quality issues through the problem solving process. · Recording and maintain the Customer Concern Log for all customer calls. · Report out on open 8-Ds at the staff and management review. · Review Supplier 8-Ds provided by the Supply Deck Manager for identification and eliminations of repeat issues. · Review Customer Requirements, IATF 16949 & ISO 14001 changes, Legal & other Requirements for current documents monthly (and checking for CSR updates). · Ensure all IATF 16949 & ISO 14001 Core Tools are completed during the PPAP process including customer specific requirements. · Facilitate Management Review Qualifications · High School Diploma/GED and minimum 10 years of experience in automotive quality or an associated degree or better with a minimum of 5 years in automotive quality. · Certifications in APQP, PPAP, PFMEA and Control Plans · Working knowledge of GD&T, blueprint reading, SPC, problem solving tools · Working knowledge of how to read and evaluate validation & dimensional reports · Experience with gage design (desired, not required) · A minimum of one program launch as a Tier 1 Quality Engineer within the last 5 years (Required for Q.E.'s hired to take on new program launch) · Advanced computer skills · Communication skills and the ability to relate to all levels of employees and management

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.

At General Motors, our product teams are redefining mobility. Through a human-centered design process, we create vehicles and experiences that are designed not just to be seen, but to be felt. We're turning today's impossible into tomorrow's standard -from breakthrough hardware and battery systems to intuitive design, intelligent software, and next-generation safety and entertainment features. Every day, our products move millions of people as we aim to make driving safer, smarter, and more connected, shaping the future of transportation on a global scale. **The Role** The ME Product Interface Quality Lead plays a critical role in driving quality excellence across the General Assembly (GA) Product Interface organization. The ideal candidate is a change agent with deep expertise in quality assurance methodology and a passion for cross-functional collaboration that will support GA Product Interface in modernizing quality systems and processes. This position serves as the primary point of contact for all quality assurance activities, ensuring alignment, compliance, and continuous improvement in risk management and quality processes while transitioning to an all-digital future. **What You Will Do** + You will support advancing GA Product Interface digital goals: + Collaborate with expert partners to leverage advanced technologies to eliminate manual and repetitive Quality tasks. + Lead efforts to build and maintain shared PFMEA Level 1 templates, helping teams stay aligned and reduce manual reviews (including supporting technology innovations). + Utilize advance collaborative tools with expert partners to proactively identify and resolve PFMEA-related issues, minimizing the need for escalation across Levels 1, 2, and 3. + Develop efficiencies and strategies to streamline RPL1/S deviation request reviews and approvals, enhancing speed and accuracy. + Drive continuous improvement and oversight of transformation activities once steady state achieved. + Support GA Product Interface in transition by: + Aligning internal and external resources through collaborative digital platforms to ensure timely and efficient PFMEA completion. + Provide updates, insights, and recommendations to leadership and stakeholders as required + Management, support and facilitation of Quality deviations + Represent the GA Product Interface organization in Quality Chain working-level discussions and escalate items as needed **Your Skills & Abilities (Required Qualifications)** + Bachelor's Degree or Equivalent experience + Excellent communication and stakeholder management skills + Ability to lead cross-functional teams and drive alignment + Detail-oriented with strong analytical and problem-solving capabilities + 3+ years' experience in PFMEA facilitation or equivalent quality systems + 2+ years' experience facilitating meetings with / presenting to Executive level leaders **What Will Give You a Competitive Edge (Preferred Qualifications)** + Expert knowledge (7+ year experience) of quality systems + 3+ years' experience working with Global Vehicle Development Process + Exposure to non-GM quality systems + Demonstrated experience in process innovation and/or continuous improvement activities **_Compensation:_** _The compensation information is a good faith estimate only. It is based on what a successful applicant might be paid in accordance with applicable state laws. The actual base salary a successful candidate will be offered within this range will vary based on factors relevant to the position, as well as geography of the selected candidate._ _- The salary range for this role is (Position 78,000 and 105,700 from Pay Transparency Posting Salary Ranges). The actual base salary a successful candidate will be offered within this range will vary based on factors relevant to the position._ _-_ **_Bonus Potential_** _: An incentive pay program offers payouts based on company performance, job level, and individual performance._ _Benefits:_ _-_ **_Benefits:_** _GM offers a variety of health and wellbeing benefit programs. Benefit options include medical, dental, vision, Health Savings Account, Flexible Spending Accounts, retirement savings plan, sickness and accident benefits, life insurance, paid vacation & holidays, tuition assistance programs, employee assistance program, GM vehicle discounts and more._ _\#LI-JK3_ \#GMrobotics-S GM does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need GM immigration sponsorship now or in the future. This includes direct company sponsorship, entry of GM as the immigration employer of record on a government form, and any work authorization requiring a written submission or other immigration support from the company (e.g., H1-B, OPT, STEM OPT, CPT, TN, J-1, etc). This role is based remotely, but if the selected candidate lives within a specific mile radius of a GM hub, they will be expected to report to the location three times a week {or other frequency dictated by your manager}. The selected candidate will be required to travel This job is not eligible for relocation benefits. Any relocation costs would be the responsibility of the selected candidate. **About GM** Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all. **Why Join Us** We believe we all must make a choice every day - individually and collectively - to drive meaningful change through our words, our deeds and our culture. Every day, we want every employee to feel they belong to one General Motors team. **Benefits Overview** From day one, we're looking out for your well-being-at work and at home-so you can focus on realizing your ambitions. 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We encourage interested candidates to review the key responsibilities and qualifications for each role and apply for any positions that match their skills and capabilities. Applicants in the recruitment process may be required, where applicable, to successfully complete a role-related assessment(s) and/or a pre-employment screening prior to beginning employment. To learn more, visit How we Hire (********************************************* . **Accommodations** General Motors offers opportunities to all job seekers including individuals with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, email (Careers.Accommodations@GM.com) us or call us at ************. In your email, please include a description of the specific accommodation you are requesting as well as the job title and requisition number of the position for which you are applying. We are leading the change to make our world better, safer and more equitable for all through our actions and how we behave. Learn more about: **Our Company (************************************************** **Our Culture** **How we hire (************************************************ Our diverse team of employees bring their collective passion for engineering, technology and design to deliver on our vision of a world with Zero Crashes, Zero Emissions and Zero Congestion. We are looking for adventure-seekers and imaginative thought leaders to help us transform mobility. Explore our global locations (******************************************** We are determined to lead change for the world through technology, ingenuity and harnessing the creativity of our diverse team. Join us to help lead the change that will make our world better, safer and more equitable for all by becoming a member of GM's Talent Community (beamery.com) (*********************************************** . 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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.

General Description Biovire Inc. is privately owned, rapidly growing Contract Manufacturing Organization that has designed a unique sterile filling and containment platform for multi-product filling of wide range of drug products and containers. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Biovire is committed to Quality and is obligated to be compliant in support of our customers. We are currently searching for a dynamic Vice President of Quality and Regulatory Affairs to join our senior management operating team. The Vice President of Quality and Regulatory will proactively develop, lead, and drive the execution of the Company's quality assurance and regulatory strategy from early stages through to commercial scale manufacturing in line with customer need and capacity expansion, balancing the business needs with regulatory compliance. Overall responsibility for leading the corporate product quality systems, including the setting of quality goals, managing, and improving all aspects of the quality system and product quality with an emphasis on customer products and expectations. The Vice President of Quality will Serve as a key and active member of the Senior Leadership team to ensure that Quality and Regulatory objectives are a key focus of the company's goals. DUTIES AND RESPONSIBILITIES Essential Duties and Responsibilities: Quality Assurance & Compliance o Serves as an active member of the Leadership Team responsible for development and setting of company Quality and Quality-related strategy and goals o Assures Biovire gains site regulatory approval o Provides leadership and direction to the Quality organization o Provides mentorship, oversight and development for the Quality Assurance, Quality Systems and Quality Control staff o Holds final accountability for and decision-making on matters relating to quality and compliance for the company o Make decisions focused on key quality- strategic and operational matters that have a significant, direction-setting impact on the company overall. o Direct and control the activities and outcomes of Quality Assurance which has a significant organizational and product impact o Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives o Ensures that the quality-related goals and objectives are accomplished o Accountable for Quality Assurance departmental staffing and must be comfortable supervising and operating in a 24/5 operation o Provides advice to the Leadership Team on regulatory compliance issues o Serves as the principal spokesman with customers, regulatory agencies, etc., on matters of regulatory compliance o Works with all Biovire employees to align and integrate the quality management system in all operational activity o Accountable for vendor adherence to all applicable quality regulations Regulatory Affairs o Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide. o Provide counsel, training and interpretation of FDA and other regulatory requirements to all company personnel. o Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies. o Develop and maintain external relationships with key opinion leaders, medical directors, and regulatory officials. o Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events. Quality Control and Microbiology o Oversee the functions of the analytical and microbiology laboratory, including: · Release of raw materials and components · In-process testing · Finished product release testing · Environmental Monitoring · Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk. Skills: WORK EXPERIENCE AND EDUCATION REQUIREMENTS Education & Experience: BA/BS undergraduate degree in life sciences, engineering, or business 15+ years pharmaceutical quality, and regulatory and experience in a sterile manufacturing, CMO, or life sciences technology driven company. Extensive experience in cGMP and other Regulatory compliance requirements. Experience in strategic planning and collaboration with executive and key operational groups. Progressive & proven record of leadership and managing quality/regulatory/analytical organization's establishing long term strategic growth initiatives. Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization. Experienced in regulatory filings for NDAs/ANDAs/Mas and other regulatory filings. Required Knowledge, Skills & Abilities: High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction. Excellent communication and presentation skills. The ability to develop and manage a high-performing team focused on accountability while meeting and exceeding expectations. Ability to lead, influence, create and work within cross-functional team environments. Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done. Success Metrics: Development and execution of Quality Assurance processes which assure site and product approvals. Execution of regulatory strategies which enable the company to achieve set objectives including product development, commercialization, and continuity of supply. With the Senior Operating team, ensure continual annual growth with corresponding profit. Preferred: M.B.A. or other relevant advanced degree Physical Requirements: Ability to sit, stand and/or walk for no less than 8 hours a day. The ability to travel domestically and internationally via plane, train and car as required, which is likely no more than 15%. Employment at Bryllan (Biovire) is contingent upon a successful Background check.

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

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.

This position is primarily responsible for performing duties as a Test Specialist including performing as the test lead on small and medium scale projects and testing initiatives; working with other testers to determine test environment set-up requirements; developing and executing systems testing; providing system expertise on small and medium scale system changes; sharing test results with members of the project team; and logging and tracking defects found in testing. Participates in product design reviews to provide input on functional requirements, product designs, schedules, or potential problems. Works collaboratively with BA's, Testers, Developers, and Internal Business Customers to investigate and explore alternatives to system issues and enhancements. PRIMARY RESPONSIBILITIES * Assist development with analysis and design for new or existing systems. * Collaborates in the analysis of advantages and disadvantages of solution alternatives as they are reviewed and a solution recommendation is made. * Participates in the pro-active review of enterprise processes and applications. Provides input that determines relative efficiency of the alternatives. * Functions as testing expert in the inspection of business and system requirements. * Works with development team to determine test approach and to translate requirements/stories into test plans, use cases, and test cases. * Provide input to Test Automation Developers in order to create new automated test cases and/or modify existing automated test cases. * Coordinate vendor testing. * Responsible for developing test cases that support the positive expected results as identified by the requirements/stories. * Responsible for developing test cases that test the negative results of the requirements/stories. Parameters for these cases are identified by the tester's business knowledge. * Responsible for using established tools and templates for ensuring test cases are clearly linked to requirements/stories. * Responsible for executing test plans, manual and automated test cases for Enterprise-wide applications and interfaces between internal and external systems. * Responsible for assisting other testing staff with developing and executing test plans. * Validate application test results to verify documented system requirements/stories. * Responsible for following the SDLC process, specifically in areas that relate to testing. * Raise awareness of application, tool and data issues as found through the testing process to ensure requirements have been addressed and all impacted systems work appropriately. * Evaluate impacted systems and applications to ensure standardization of presentation format, usability and reporting. * Assist in the testing of user documentation developed for training to validate that systems perform as designed. * Assist in providing use case demonstrations to internal business customers. * Identify, analyze, and retest defects relating to system changes, procedures, or workflows in regards to requirements, stories or specifications. * Ensure defects found in testing are resolved (fixed or approved to go to Production by customer) prior to Test Approval. * Responsible for ensuring the project planning systems are kept current for assigned testing initiatives. * Ensure customer approval of test results is obtained prior to moving code to Production. * Responsible for creating and maintaining test management documentation, and for creating and distributing reports and communicating directly with the customer. * Assist in reviewing, evaluating and making recommendations for process improvements. * Assist in developing documentation for testing tools and conducting training for same. * Periodically participate in groups/committees related to processes, standards and best practices. * Responsible for understanding, using and retaining the technical and business knowledge of the Enterprise for testing purposes. * Participates in the problem management process including data related discrepancies between systems. * Leads testing initiatives for assigned Enterprise projects, department projects and change requests (communication; providing subject matter and testing expertise; coordinating testing resources such as environment set up, tools and templates, access to applications, and other needs). * Maintains confidentiality of information processed as appropriate. EMPLOYMENT QUALIFICATIONS EDUCATION REQUIRED Associates degree in Information Technology, Business or related field. Combination of relevant education and experience may be considered in lieu of a degree. EXPERIENCE REQUIRED Two years of software quality assurance and testing of business systems required. SKILLS/KNOWLEDGE/ABILITIES (SKA) REQUIRED * Thorough understanding of software development lifecycles. * Thorough knowledge of testing philosophies, methodologies, workflow and software tools that supports them. * Working knowledge of automated testing tools and how they are used. * Ability to interpret program logic, prepare test data, and execute test plans. * Excellent understanding of the various types and phases of testing. * Excellent verbal, written, and presentation communication skills. * Ability to apply the principles of independent logical thinking to define problems, collect data, establish facts and draw valid conclusions. * Ability to establish acceptable workloads and expectations. * Ability to comprehend the consequences of various problem situations and take appropriate actions or refer them for appropriate decision making. * Working knowledge of computer systems and integrations. * Ability to develop and execute test plans and test cases. * Ability to communicate effectively to clearly and concisely communicate factual and technical information. * Excellent organizational skills and ability to manage multiple priorities establish workflows and meet necessary deadlines. * Excellent analytical and problem-solving skills. * Knowledge of computers, word processing, and spreadsheet software. * Basic knowledge of relational databases. * Ability to enter and verify alpha/numeric data accurately. * Ability to perform basic mathematical calculations. * Ability to proofread documents for accuracy of spelling, grammar, punctuations, and format. * Ability to adapt to changing priorities and demands. * Ability to take direction and execute accordingly. ADDITIONAL EDUCATION, EXPERIENCE, SKILLS, KNOWLEDGE AND/OR ABILITIES PREFERRED Experience in insurance business systems, knowledge of workers' compensation insurance, and experience working with relational databases highly preferred. Ability to create and execute SQL queries for use in testing and validating systems which have relational databases. WORKING CONDITIONS Work is performed in an office setting with no unusual hazards. REQUIRED TESTING (For HR use only) Intermediate Windows, Intermediate Excel, Intermediate Word. Alpha Numeric. Math. Reading Comprehension. Proofreading. We are an Equal Opportunity Employer. Diversity is valued and we will not tolerate discrimination or harassment in any form. Candidates for the position stated above are hired on an "at will" basis. Nothing herein is intended to create a contract.

Job Description Title: Supervisor I, Quality Reports to: Manager, Pack QA LG Energy Solution Michigan Inc. (LGESMI) develops and manufactures large lithium ion polymer batteries and packs for electric vehicle (EV) and energy storage applications. Come join the leader in advanced EV batteries! ****************** Summary: As a Quality Supervisor, you will be responsible for ensuring quality standards in accordance with the requirements of the organization. Responsibilities: Evaluate operators' level periodically with proper training to improve the inspection level Audit and support organization quality standard compliance Manage periodic audit data and deliver to part leaders to escalate In line Return/Field return Sample Analysis and report to HQ if the issue caused from components Lead process investigations to improve process stability and capabilities on Cell and Pack components/products from its root cause Close communication with multi-functional teams, including Production, Purchasing, etc. Official Communicating and Presenting of Quality Process to who needs to learn it Maintain Lab and Train testing equipment/method with proper instruction including CMM Frequent communication with relevant team in Holland, and Hazel Park to share and implement verified corrective actions from headquarters and engineer Conduct inspection and cause analysis regarding the raw material and product quality non-conforming issues Document and follow up on SOP's Maintain related records, logs, and paperwork Ensure all team members are utilizing time effectively Maintain cleanliness at work-site in accordance with 5S3R Standards: Sort, Set in order, Shine, Standardize, Sustain Right Location, Right Quantity, Right Container Conduct thorough and timely Layered Process Audits in appropriate work areas Perform other duties as assigned Qualifications: High School Diploma or GED required Vocational Certificate or Associates Degree preferred or equivalent, relevant experience Experience: 3 to 6 years of related experience 1 to 3 years of leadership experience Manufacturing experience preferred Skills: Planning and organizational skills Timely decision-making Composure and effective communication skills Problem solving and critical thinking skills Creativity and innovation Ability to lead with compassion and equity Experience and knowledge of composition analysis, key parameter analysis, and GD &T Experience and knowledge of SOP, Control plan, CTQ, SPC Good capability to use MS-office and Minitab program Ability to travel to other business sites weekly or as necessary Ability to work flexible hours as needed to support entire production team

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

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.

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. Qualifications Bachelors Degree required. 8 years minimum engineering or quality experience. 3 years minimum previous supervision or management experience.

Job Description Quality Manager | St. Johns, MI Salary Range: $92,000 - $139,000 depending on experience Are you a dedicated professional with a passion for upholding and enhancing production standards? The Pivot Group is committed to fostering meaningful relationships and supporting career growth. We partner with leading manufacturing companies in St. Johns, seeking experienced Quality Managers to strengthen their teams. The Opportunity We are partnering with organizations in St. Johns that are seeking Quality Managers. These companies are committed to building strong teams and are looking for professionals who can lead initiatives effectively. By connecting with Pivot Group, you position yourself for roles that match your background and aspirations. Key Responsibilities Develop, implement, and maintain the Quality Management System (QMS). Lead and manage all aspects of product quality assurance and control. Conduct internal and external quality audits to ensure compliance with standards. Drive root cause analysis and implement corrective and preventive actions for non-conformances. Manage and mentor the quality assurance team, fostering a culture of quality. Monitor and improve manufacturing processes to reduce defects and waste. Oversee supplier quality management and performance. Recommended Qualifications Bachelor's degree in Engineering, Quality Management, or a related technical field. 5+ years of progressive experience in quality management within a manufacturing environment. In-depth knowledge of ISO 9001 and other relevant industry-specific quality standards (e.g., IATF 16949, AS9100). Proficiency in quality methodologies and tools (e.g., SPC, FMEA, Root Cause Analysis, Lean, Six Sigma). Proven leadership and team management skills, with experience developing and implementing quality strategies. Bonus Qualifications Lean Six Sigma Green or Black Belt certification Certified Quality Auditor (CQA) or Lead Auditor certification (e.g., ISO 9001) Experience with advanced statistical analysis software (e.g., Minitab, JMP) Project Management Professional (PMP) certification Job Titles That Should Apply Quality Manager, QA Manager, Quality Assurance Manager, Quality Control Manager, Senior Quality Manager, Director of Quality, Head of Quality, Quality Systems Manager Why Pivot Group The Pivot Group was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic-they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out. The Pivot Group offers resources to support your search-market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.

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.