Job Description
We are searching for the best talent for a Staff Quality Engineer to be located at Markham, Ontario, Canada. The Staff Quality Engineer provides independent quality oversight for drug and medical device products marketed in Canada, ensuring compliance with Health Canada regulations, including Health Canada Food and Drugs Act, GUI‑0001 (GMP for drug products) and Medical Devices Regulations (SOR/98-282).
Key Responsibilities
- Lead and support the implementation and maintenance of Quality Management Systems (QMS) in alignment with corporate standards and Canadian regulatory requirements for Drugs and Medical Devices.
- Initiate, investigate, review, and approve quality records including NCs, deviations, CAPAs, change controls, and validation documentation; ensure procedures exist for recording, evaluating, investigating, trending quality events and system performance; maintain audit‑ready documentation and traceability of GMP records.
- Serve as pr...