Associate Manager, Medical Device Quality (Sustaining Engineering)
$90.8k/y-$173.4k/y
BioSpace2 days ago
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OnsiteContractorSenior
Summary
BioSpace is seeking an Associate Manager, Medical Device Quality (Sustaining Engineering) to join their team in East Greenbush, NY. The role involves providing QA oversight of medical device functions, including combination products and supporting sustaining engineering programs.
About the Role
As an Associate Manager, Medical Device Quality, you will lead a team in sustaining engineering support, conduct risk evaluations, maintain design history files, and provide QA oversight during the commercialization phase of combination products. You will also represent the medical device QMS during regulatory inspections and collaborate with internal and external partners.
About You
Required:
- Bachelor's degree in Mechanical or Biomedical Engineering or equivalent.
- 6+ years of experience in Quality Assurance and Quality Risk Management in the medical device/combination products field.
Preferred:
- 7+ years of experience in the pharmaceutical/medical device/biotechnology industry.
- Excellent written, oral, and interpersonal communication skills.
Benefits
- Health and wellness programs.
- Fitness centers.
- Equity awards.
- Annual bonuses.
- Paid time off for eligible employees.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.
East Greenbush, NY