Senior Quality Engineer

Role: Senior Quality Engineer responsible for supporting quality improvement initiatives, process validation, and compliance in a regulated medical device environment. Responsibilities include managing non-conformance reports, conducting internal and supplier audits per ISO-13485/21CFR820, developing process monitoring/control methods (including FMEA), analyzing data for process improvements, and overseeing CAPAs and customer complaints. Requirements: Engineering or technical degree with 5+ years of experience (or Master's with 3+ years); proficiency in IQ/OQ/PQ, statistical analysis, and electronic QMS systems (Trackwise preferred). Experience in regulated environments such as medical devices or pharma is preferred. High-Value: Medical device/biopharma industry, quality management, process validation, regulatory compliance, ISO-13485, 21CFR820, risk management, GxP practices. Collaboration with manufacturing, suppliers, and internal teams. Work setup: not specified; salary range $81,650–$112,700 USD. The role emphasizes leadership in quality systems and continuous improvement aligned with business and quality vision.