Quality Engineer II

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. 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. Maintain and manage documentation and change records within Agile PLM. Top 3 technical skills that are required for the role: 1. Experience supporting, writing and executing process validation and test method validations. 2. Experience creating and maintaining PFMEAs, Control Plans, and risk documentation aligned with medical device quality systems. 3. 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 years relevant experience (experience in MDR highly preferred)