Senior Medical Device Quality Engineer to complete onboarding activities for both sustaining and merger & acquisition (M&A) quality support

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, manufacturin g, 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. Apply

Location: Toronto, CA

Posted Date: 9/28/2024