Assoc Quality Systems Specialist - 18 months contract
$54,400–$68,000 year
On-site · Brampton, Ontario, Canada
Job Summary
Assoc Quality Systems Specialist coordinating Field Corrective Actions (FCA) across Canada with liaison between local QARA, field teams, and global OU Quality leadership; responsible for planning, documentation, and training related to FCA deployment, regulatory compliance, and continuous improvement within a 18-month contract based in Brampton, Ontario; requires a Baccalaureate degree and 0 years experience, with nice-to-have BA in Life Sciences and at least 2 years in quality/regulatory roles; English fluency and knowledge of medical device regulatory requirements (FDA, EU MDR, ISO 13485, Health Canada) are essential.
Required Qualifications
- Requires a Baccalaureate degree (or degree satisfying 8 C.F.R. § 214.2(h)( 4)(iii)(A))
- 0 years of experience required
- Nice to have: Bachelor’s degree in Life Sciences or related field
- Minimum of 2 years of experience in quality systems or regulatory affairs, plus at least 2 years of project management experience in a regulated environment
- Fluency in English, both written and spoken
- Basic understanding of global regulatory requirements for medical devices (FDA, EU MDR, ISO 13485, Health Canada)
- Strong project management capabilities
Desired Qualifications
- Bachelor's degree in Life Sciences or a related field
- Minimum of 2 years of experience in quality systems or regulatory affairs
- Plus at least 2 years of project management experience in a regulated environment
- Fluency in English, both written and spoken
- Basic understanding of global regulatory requirements for medical devices (e.g., FDA, EU MDR, ISO 13485, Health Canada)
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