Quality Engineer
Roles & Responsibilities
- Conduct Global Regulatory Impact Assessments (GRIA) and manage field action documentation.
- Support MMS field action team in drafting customer letters and tracking recalls.
- Ensure audit readiness and compliance with regulatory standards.
- Oversee MMS-related Canadian recall activities.
- Participate in post-market surveillance and policy updates.
- Maintain official field action files, ensuring proper documentation and audit readiness.
- Track recall activities and compile final closure documentation.
- Assist in the development, review, and training of Post Market Quality policies.
Experience Required
- 1-2 years of relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry.
- Experience in post-market surveillance and/or post-market quality (preferred).
- Experience working with ERP and QMS systems.
Skills & Certifications
- Excellent problem-solving, communication, and collaboration skills.
- Ability to work across teams and regions in a fast-paced environment.
- Strong organizational skills with attention to detail.
- Ability to manage multiple tasks and meet deadlines.
Eligibilities & qualifications
- Bachelor’s degree in a relevant field.
- Ability to work flexible hours in PST.
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