MDR - Quality Engineer II - Exempt

Role SummaryThe Quality Engineer (QE) supports MDR remediation activities and ongoing manufacturing quality assurance for designated product families at the Dexter site. The role focuses on ensuring manufacturing processes, labeling, packaging, and documentation comply with internal quality standards and regulatory requirements. The QE collaborates closely with manufacturing, planning, warehouse operations, and product engineering to assess risks, implement process controls, and support product and process changes required for MDR compliance. Day-to-Day Responsibilities

• Conduct First Article Inspections (FAIs) and complete associated documentation and reports.
• Develop and maintain risk management documents (pFMEAs) and Control Plans for product families and technical files.
• Conduct production floor observations and process tours to ensure risk assessments reflect current manufacturing practices.
• Collaborate with manufacturing, quality, and product engineering teams to gather input for risk assessments and MDR updates.
• Coordinate with MDD/product engineers to align on product family updates and MDR-related changes.
• Perform packaging or fit testing (e.G., carton dimension changes) and document results in formal reports.
• Review, collaborate on, and approve manufacturing change orders.
• Coordinate label printing and shipping activities with production line leads/supervisors and planning as needed.
• Perform label verification and grading activities and generate associated reports.
• Work with warehouse personnel to obtain components required for product testing and evaluations.
• Maintain and manage documentation and change records within Agile PLM.

Top 3 Technical Skills Required for the Role

• Experience supporting, writing and executing process validation and test method validations.
• Experience creating and maintaining PFMEAs, Control Plans, and risk documentation aligned with medical device quality systems.
• Experience performing FAIs, dimensional verification, and evaluating manufacturing or packaging changes.

Education and Experience Required

• Bachelor’s degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field).
• Bachelor’s Degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 1 year relevant experience (experience in MDR highly preferred).

Additional Information

• This position requires working 40 hours a week onsite in Dexter, MI, a vibrant community known for its welcoming atmosphere and beautiful surroundings.
• Interviews will be scheduled as soon as candidates are available.
• This role will support all product lines manufactured at the Dexter site.

Responsibilities May Include the Following and Other Duties May Be Assigned:Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment;conducts quality assurance tests;and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.Specialist Career Stream: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).Differentiating Factors:

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists;may manage projects/processes.
• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
• Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others'work product.
• Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.