Quality Engineer II - Exempt

Join our team in Dexter, MI, a vibrant community that offers a perfect blend of small-town charm and modern amenities. Enjoy a fulfilling career in a location known for its beautiful parks, excellent schools, and a strong sense of community.

Must Have

• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecycle (from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with Minitab)

Other Skills

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices
• Conducted test method validation analysis
• Creating Control Plans
• Creating inspection sampling plans
• Developing packaging validation plans
• Develop the Risk Evaluation

Nice to Have

• 1-3 years medical Device experience

Role Summary

The 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

• 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 Required

Bachelor’s degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field).

Years’ Experience Required

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).

Work Schedule and Location

This is a full-time position requiring 40 hours per week, and it is onsite at our Dexter, MI location.

Responsibilities

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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.