Medtronic
Healthcare
SeniorQualityEngineer
“Senior Quality Engineer at Medtronic. Skills: Risk Management, PSUR, EU MDR. Prepare and compile product post market data. Serve as mentor to junior engineers”
Industry & Context.
What They're Looking For.
Must Have
BETech, 8 to 12 years of experience in Risk Management, Experience on PSUR or some in Post market quality experience, Hands on experience on EU MDR
Nice to Have
Clinical medical writers, Signal Evaluations
What You'll Do.
Prepare and compile product post market data
Serve as mentor to junior engineers
Provide guidance and support in quality engineering practices
Collaborate with cross-functional teams to gather data
Analyze data related to performance and safety
Draft and author PSUR or CER documents
Partner with regulatory affairs to ensure submission
Ensure accurate and timely submission of PSURs
Continuously monitor evolving safety regulations
Stay updated with evolving safety regulations
Ensure PSUR compliance
Develop templates based on quality system regulations
Develop training based on quality system regulations
Review all deliverables for compliance
Ensure compliance with development process
Ensure compliance with the standard
Collaborate with engineering functions
Collaborate with regulatory affairs functions
Collaborate with manufacturing functions
Ensure submission of safety reports
Deliver presentations to QA organization
Deliver training to QA organization
Participate in audits
How You'll Work.
Team & Collaboration
Cross-functional teams; Regulatory affairs; Medical experts; Engineering functions; Manufacturing functions; QA organization
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