MDR Sr Quality Engineer

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 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience (experience in MDR highly preferred)

TECHNICAL SKILLS

Must Have 1-3 years of Medical Device industry experience, Familiar with

FDA 21 CFR

Part 820, EU 217/745 (EU MDR), • Familiar with these standards:

ISO 13485, ISO 14971, IEC

60601, Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS. 1. Experience in equipment IQ 2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation 3. Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification) 4. Preferred experience in DOE (with minitab) Other skills: 1. Computer and software validation

CSV 2. SOP

Development 3. Change control of Medical Devices 4. Nice To Have 1-3 years of Medical Device industry experience