Associate Manager, Medical Device Quality (Sustaining Engineering)
Regeneron Pharmaceuticals(4 months ago)
About this role
Manager on the Medical Device Sustaining Engineering QA team providing quality oversight for combination products such as pre-filled syringes and auto-injectors/pen injectors for biological therapeutics. The role supports application of quality risk management through device development, transfer, and commercialization while collaborating with internal and external partners and CMOs. It focuses on post-transfer and commercial phase activities to maintain compliance and product quality.
Required Skills
- Quality Assurance
- Quality Risk Management
- Design Control
- Design Reviews
- Risk Assessment
- Design History File
- Sustaining Engineering
- Regulatory Inspections
- Team Management
- Supplier Management
Qualifications
- BS in Mechanical Engineering
- BS in Biomedical Engineering
- 7+ Years Experience in Pharmaceutical/Medical/Biotech
About Regeneron Pharmaceuticals
regeneron.comDiscover how Regeneron (NASDAQ: REGN) harmonizes biology and technology to create life-changing medicines. Join our team and explore clinical trials.
View more jobs at Regeneron Pharmaceuticals →Apply instantly with AI
Let ApplyBlast auto-apply to jobs like this for you. Save hours on applications and land your dream job faster.
More jobs at Regeneron Pharmaceuticals
QA Validation Specialist
Regeneron Pharmaceuticals(7 days ago)
Temp QC Analyst (HPLC/Micro/Tech Resource)
Regeneron Pharmaceuticals(7 days ago)
Process Development Engineer III Analytics Automation
Regeneron Pharmaceuticals(7 days ago)
Director, Culture & Inclusive Science
Regeneron Pharmaceuticals(7 days ago)
Similar Jobs
Sr Human Factors Engineer I
Gilead Sciences(3 months ago)
Senior Scientist/Engineer, Medical Device and Combination Products, Analytical
MSD(1 month ago)
Associate Director, Drug/Device Combination Products Tech Transfer
MSD(1 month ago)
Sr Human Factors Engineer II
Gilead Sciences(2 months ago)
Senior Manager, Device Quality Engineering
Takeda Pharmaceutical Company(1 month ago)
Sr Quality Engineer I
Gilead Sciences(2 months ago)