S.i. Systems client is looking for a Senior Supplier 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, manufacturin g, pharmaceutical, aerospace, medical devices or highly regulated environment
- Lead Quality Auditor Certification either in ISO or ISO 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 , 21 CFR Part standards .
- Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment.
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