Sr. Engineer, Quality

Role: Senior Quality Engineer supporting the development, manufacturing, and distribution of healthcare products, with a focus on biologics, human tissue, or medical devices. Responsibilities: ensure compliance with international and domestic quality regulations (e.g., QSR, ISO 13485, 21 CFR), lead risk management, design control, validation, and quality improvement initiatives; collaborate across departments including Product Development, Clinical, and Manufacturing; conduct root cause analysis and supplier quality management; participate in audits and inspections; develop inspection methods and metrics for quality monitoring. Requirements: minimum of a BS in Biomedical, Mechanical Engineering, or related field; 5+ years in Quality Engineering/QA within medical device or pharma manufacturing; expertise in design controls, statistical analysis (e.g., Minitab), FMEA, root cause methodologies, and regulatory standards. Preferred: certifications such as ASQ CQE, Lead Auditor, Six Sigma Black Belt; experience with CGMP, QSR, ISO standards. HighValue: medical device/biologic manufacturing, regulatory compliance, risk management, validation, supplier quality, and cross-functional collaboration. WorkSetup: APC location; up to 30% travel.