Senior Quality Engineering Specialist (Medical Device)Location: Waterloo, Ontario
Position Vacancy Type: New Position
Compensation Range: $95,000.00 - $120,000.00 per yearTHE IMPACT YOU'LL MAKE: Reporting to the Senior Manager, Quality Assurance & Regulatory Affairs, the Senior Quality Engineering Specialist-Medical Device plays a key role in ensuring NDI products meet global regulatory requirements.
In this role, you will support the full product lifecycle, including development, commercialization, and post market performance of medical devices. This role ensures products meet safety, performance, and regulatory requirements through the application of risk-based quality engineering principles and robust quality systems.
You will act as a key quality partner across R&D, manufacturing, and regulatory teams-driving design quality, leading investigations, and ensuring compliance with ISO 13485, FDA QSR, and global regulatory requirements.
HOW YOU'LL CONTRIBUTE: - Lead quality engineering activities across the product lifecycle, including design, transfer, and post market support.
- Own and ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations.
- Provide expert leadership in design controls, including:
- Design inputs/outputs.
- Verification and validation strategy and execution.
- Design reviews and change management.
- Lead risk management activities (FMEA, hazard analysis) in accordance with ISO 14971.
- Own and drive complex investigations, including complaints, nonconformances, MRB, CAPAs and SCARs.
- Analyze field performance and quality data to identify systemic issues and lead improvement initiatives.
- Review and approve quality documentation including DHF, DMR, DHR, and technical files.
- Support regulatory inspections and external audits (FDA, ISO, MDSAP).
- Support process validation and manufacturing quality activities including sterilization and packaging.
- Collaborate with cross-functional teams to ensure quality is embedded in design and production.
- Support supplier quality activities, including qualification and audits.
- Drive continuous improvement initiatives to enhance product quality and compliance.
EDUCATION AND PROFESSIONAL QUALIFICATIONS:- Bachelor's degree in Engineering, Biomedical Engineering, or related field (or equivalent experience).
- 9+ years of experience in quality engineering within a regulated industry (medical device preferred).
- Working towards or certified as a Certified Quality Engineer.
ADDITIONAL STRENGTHS:- ISO 13485:2016 Lead Auditor Certification an asset.
- Strong knowledge of:
- ISO 13485 and FDA QMSR (21 CFR Part 820).
- Risk management (ISO 14971).
- Design controls and validation.
- Experience with CAPA, NCR, complaints handling, and audits.
- Familiarity with statistical tools (SPC, DOE, Six Sigma).
- Strong analytical and problem-solving skills.
- Excellent communication and cross-functional collaboration abilities.
- High attention to detail and commitment to product safety.
THE BENEFITS OF JOINING OUR TEAM - Competitive pay with a 4% RRSP match to help you plan for the future.
- A comprehensive benefits package that supports your health and well-being.
- Company-wide bonus program and regular salary reviews.
- Employee Stock Purchase Plan offering discounted company shares to help you invest in and benefit from our growth.
- A 37.5-hour work week with a hybrid work model available where responsibilities allow.
- Receive 15 vacation days starting on day one, plus a paid holiday shutdown in December to recharge before the New Year!
- A calendar full of employee social events and engagement activities to keep us connected.
- Professional and personal development support designed to foster your continuous growth and career advancement.
- Work where your contributions are valued - as a multi-year winner of Waterloo Region's Top Employers and the 2025 Chamber of Commerce Business of the Year, we're recognized for putting people first and fostering a culture of collaboration and excellence.
- Part of a growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
- Conveniently located near GRT and ION transit stops, with free on-site parking available.
If you're looking to join a collaborative and curious team-guided by integrity, bold thinking, and a commitment to doing things right-this could be the team for you. We believe in supporting one another and working together to find creative solutions. You'll be surrounded by people who are passionate about what they do and driven by work that truly makes a difference. If this sounds like the right fit for you, we invite you to apply online and introduce yourself. We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.
