MDR - Sr Quality Engineer - Exempt

Join our team in Dexter, MI, where you will be at the forefront of ensuring quality and compliance in the medical device industry. This role offers an exciting opportunity to work in a dynamic environment, supporting MDR remediation activities and ongoing manufacturing quality assurance for our diverse product lines. Must Have 1-3 years of Medical Device industry experience Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR) Knowledge of standards: ISO 13485, ISO 14971, IEC 60601 Proficiency in Microsoft Office Applications (Word, Excel, Access, PowerPoint) and Windows OS Experience in equipment IQ, OQ (Operational Qualification), and PQ (Performance Qualification) or process validation Process Validation Lifecycle expertise Preferred experience in DOE (Design of Experiments) with Minitab Skills in Computer and Software Validation (CSV), SOP Development, and Change Control of Medical Devices Nice to Have: 1-3 years of Medical Device industry 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 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 and Experience Required: Bachelor’s degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field) and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience (experience in MDR highly preferred). Work Schedule 40 hours/week, onsite at Dexter, MI. Additional Responsibilities Responsibilities may include developing, modifying, applying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials product. Collaborating with engineering and manufacturing functions to ensure quality standards are in place. Devising and implementing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Designing or specifying inspection and testing mechanisms and equipment; conducting quality assurance tests; and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.