Senior Quality Engineering Specialist
- Waterloo, ON
- Hybrid
- Posted May 14, 2026
- 1 position
$95,000–$120,000 / year
Opens an external site
- Employment type
- Full-time
- Experience level
- Lead · 10+ years
- Minimum education
- Bachelor’s degree
- Posting language
- English
- Working hours
- 38 hours per week
Job summary
Lead quality engineering activities across the medical device product lifecycle to ensure compliance with global regulatory requirements. Drive design quality, lead complex investigations such as CAPAs and nonconformances, and support regulatory inspections.
Job details
Lead quality engineering activities across the medical device product lifecycle to ensure compliance with global regulatory requirements. Drive design quality, lead complex investigations such as CAPAs and nonconformances, and support regulatory inspections. Requires a Bachelor's degree in Engineering or a related field and over 9 years of experience in quality engineering within a regulated industry. Proficiency in ISO 13485, FDA QSR, and risk management standards is essential.
What you’ll do
Lead quality engineering activities across the medical device product lifecycle to ensure compliance with global regulatory requirements. Drive design quality, lead complex investigations such as CAPAs and nonconformances, and support regulatory inspections.
Requirements
Requires a Bachelor's degree in Engineering or a related field and over 9 years of experience in quality engineering within a regulated industry. Proficiency in ISO 13485, FDA QSR, and risk management standards is essential.
Benefits
- 4% RRSP Match
- Comprehensive Health and Well-being Benefits
- Company-wide Bonus Program
- Regular Salary Reviews
- Employee Stock Purchase Plan
- Hybrid Work Model
- 15 Vacation Days
- Paid Holiday Shutdown in December
- Employee Social Events
- Professional and Personal Development Support
- Free On-site Parking
Listed skills
- Risk Management · Preferred
Other relevant skills
Identified from the job description. Confirm important requirements above.
- Quality Engineering
- ISO 13485
- FDA 21 CFR Part 820
- ISO 14971
- Risk Management
- Design Controls
- CAPA
- Verification and Validation
- FMEA
- Statistical Process Control
- Design of Experiments
- Six Sigma
- Audit Management
- Complaint Handling
- Process Validation
- Supplier Quality
Job areas
- Engineering
- Healthcare
- Manufacturing
- Science & Research
- Management & Leadership