Senior Quality and Regulatory Manager
Grove Collaborative
Senior Quality Engineer
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • Tennessee
Visit company websiteSalary
💰 $96,800 - $145,200 per year
Job Level
Senior
About the role
- Serve as the quality point of contact for manufacturing lines, providing guidance on quality issues and helping ensure day-to-day compliance.
- Monitor and analyze process and product performance data to identify trends, drive root cause analysis, and support continuous improvement.
- Lead or support nonconformance investigations, risk assessments, and corrective/preventive actions (CAPA) related to manufacturing processes.
- Develop and execute validation of manufacturing processes, equipment, spreadsheets and software (IQ/OQ/PQ).
- Write, review and/or approve work instructions, inspection plans, process changes, and deviations.
- Participate in internal and external audits, ensuring readiness and effective response to findings.
- Champion the use of Lean Six Sigma, statistical tools, FTQ and problem-solving methodologies.
- Collaborate cross-functionally with operations, engineering, and supply chain to ensure product quality and operational efficiency.
- Perform reviews of Device History Records for product complaints
- May serve as a Subject Matter Expert (SME) for assigned manufacturing processes, equipment or software.
Requirements
- Minimum Requirements: Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR PhD with 0 years of experience
- Nice to Have: Validation experience (IQ, OQ, TMV, PQ); Software validation experience; 5+ years of related quality engineering experience; Previous Quality experience working in medical device or related industry; Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant international standards; Experience in DMAIC methodology; Certified Lean or Six Sigma Green Belt a plus; Working experience with SAP, inspection software, Excel macros; Experience interacting with PowerBI; Strong communication, presentation and collaboration skills; Comfortable working with international and multi-cultural department & groups in different time zones; Ability to work well under pressure and maintain positive, enthusiastic attitude; Ability to work in a fast-paced environment; Eagerness to learn and expand responsibilities & accountability
