Design Quality Engineer. Job in Millcreek Twp LilyLifestyle Jobs

Job Title Responsibilities Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation. Ensure full compliance with design control standards such as 21 CFR 820 and ISO 13485. Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO 14971. Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle. Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes. Lead or support design verification and validation planning, execution, protocol creation, and report writing. Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance. Develop, revise, and ensure adherence to QMS procedures covering ISO 13485, cGMP, and 21 CFR Part 820, including document control, CAPA, and audit readiness. Support internal and supplier audits, regulatory inspections, and ensure follow-up with corrective actions. Investigate product deviations and process non-conformances, lead root cause analysis, and implement CAPA or Client actions. Monitor the effectiveness of corrective actions and maintain relevant documentation. Qualify suppliers, review supplier documentation, and support pilot/production transfer to align with Critical to Quality (CTQ) requirements. Requirements Collaborate with manufacturing engineering to implement process improvements and validate manufacturing outputs. Stay current with relevant regulations (FDA, EU MDR, ISO 10993, etc.) and integrate best practices into quality systems. Provide regulatory submission support for 510(k) or similar filings. Educate engineering and manufacturing teams on design and quality requirements, quality tools, and compliance standards. #J-18808-Ljbffr