Senior Medical Device Quality Engineer to complete onboarding activities for both sustaining and merger & acquisition (M&A) quality support
S.i. Systems
Toronto, ON-
Number of positions available : 1
- Salary To be discussed
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Contract job
- Published on September 10th, 2024
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Starting date : 1 position to fill as soon as possible
Description
S.i. Systems client is looking for a Senior Medical Device Quality Engineer to complete onboarding activities for both sustaining and merger & acquisition (M&A) quality support
12 month contract to start, Ontario based candidates only. Some travel required to sites in Ontario, Quebec & US. All expenses covered.
Must Haves:
- 5+ years' experience in quality, engineering, manufacturing, pharmaceutical, aerospace, medical devices or highly regulated environment
- Lead Quality Auditor Certification either in ISO13485 or ISO 9001 or comparable industry standards and regulatory requirements
- Understanding of US, EU and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
- Knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
- Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment.
Requirements
undetermined
undetermined
undetermined
undetermined
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