Quality Assurance Engineer II (Molding)

Quality Assurance Engineer II (Molding) focused on medical devices. Evaluates, selects, and applies standard engineering techniques to molding processes, works on standard projects with guidance on unusual problems, and contributes to risk management documentation for mold product lines. Responsibilities include updating ECNs for mold verification/validation, monitoring and inspecting methods, reviewing nonconformance records for disposition and root cause, implementing corrective and preventive actions, ensuring containment of nonconforming product, and maintaining the effectiveness of the quality management system through data analysis and policy objectives. Requires familiarity with 21 CFR 820, ISO 13485, ISO14791, and experience with statistical methodologies and manufacturing tools (lean, Six Sigma). Preferred qualifications include medical device experience and experience handling non-conformances and CAPAs, plus experience in mold validations. The role may involve design and development support for mold activities and participates in cross-functional teams; multiple shifts/hours and benefits are described in the posting.