Quality Engineer - Medical Devices

Quality Engineer - Medical Devices at Mack Molding Company

Arlington, VT – $65,000.00 – $

• Provide quality engineering support during new business development, program launches, and for existing customers.
• Ensure manufacturing processes, quality systems, and finished products for medical devices meet all applicable regulatory, customer, and internal quality requirements.
• Work in an ITAR-controlled environment, adhering to strict compliance requirements.
• Support new business development related to quality matters as needed.
• Draft preliminary Quality Plans when appropriate and provide cost and time estimates for anticipated quality department services such as metrology or validation services.
• Serve as a resource for CFR Part 820 and ISO 13485 regulatory requirements.
• Represent the functional department in program launch and product realization, reviewing new program drawings, customer specifications, and program requirements.
• Support customer audits, regulatory inspections, and certification.
• Draft program Quality Plans, PFMEAs, Dynamic Control Plans, and other required quality documentation, including Dimensional Visual Quality Requirements (DVQRs) and new product inspection techniques.
• Confirm customer agreement on GD&T callouts/interpretations and all critical dimensions of a program when required.
• Prepare manufacturing job travelers and associated process documents.
• Develop required control/test methods.
• Ensure that First Article Inspection (FAI) and capability studies are scheduled, completed, and analyzed for submission to the customer.
• Generate validation plans, operational qualification (OQ), and performance qualification (PQ) protocols, and provide training for protocol participants.
• Oversee the execution of assigned validation activities to ensure compliance with protocol requirements and completion of study tasks.
• Generate required validation completion reports, including resolution of any deviations and overall study conclusions.
• Perform first-piece and in-process approvals for new setups, tooling changes, or process adjustments.
• Attend program team meetings to support production-related matters and perform assigned activities in a timely manner.
• Provide continuous quality engineering support through program end of life.
• Complete Certificates of Conformance (CoC) for outgoing products, where required.
• Collect and analyze production line data to monitor yield and defect performance.
• Use statistical tools (SPC, DOE, capability studies) to identify process improvement opportunities.
• Maintain Device Master Records, including Device History Records, as required.
• Perform periodic risk assessments, as required.
• Assist the Purchasing Department with maintaining vendor quality requirements.
• Continuously monitor production to identify quality-related customer issues and support corrective action plans when necessary.
• Issue or authorize customer complaints and returns as needed.
• Manage the return of goods, assignments, and close out of RC/CA.
• Document nonconformances, conduct thorough root‑cause analyses, and develop and implement effective corrective action plans.
• Manage product and process change control and notify required Engineering Change Orders (ECOs) to ensure approval by the customer prior to implementation.
• Attend program team meetings as necessary to resolve program quality issues and maintain customer satisfaction.
• Support quality business reviews with the customer and present/ discuss quality-related topics.
• Participate in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes.

• Strong technical background with problem‑solving skills.
• Working knowledge of statistical techniques and tools (Minitab), sampling plans, and statistical methods used in quality.
• Strong analytical and root‑cause problem‑solving skills (5‑Whys, Fishbone, 8D).
• Knowledge of quality systems regulations and ISO standards, including ISO 13485 and CFR Part 820.
• Experience with Advanced Product Quality Planning (APQP).
• Familiarity with multiple manufacturing processes (e.g., injection molding, machining, assembly, packaging).
• Occasional domestic travel required.
• Other duties as assigned.

Entry level

Full‑time

Quality Assurance

Plastics Manufacturing