Senior Quality Engineering Specialist

Northern Digital Inc.; Southwestern Ontario; Hybrid; CAD 95,000 - 120,000; Full time

Benefits offered by this job

RRSP match

Benefits package

Bonus program

Employee stock plan

Hybrid work

Vacation days

Professional development

Top Employer recognition

Job summary

Northern Digital Inc. (NDI) seeks a Senior Quality Engineering Specialist to lead quality engineering across the medical device product lifecycle, from design through post-market support, in Waterloo.

You will ensure conformance to ISO 13485, FDA QSR, and global standards, drive risk management and investigations, and collaborate with R&D, manufacturing, and regulatory teams. Hybrid work options and a comprehensive benefits package are provided.

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.

Responsibilities

• 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.
• 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.

Skills

Quality engineering

Regulatory compliance

Risk management

Design reviews

CAPA handling

Investigation leadership

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Biomedical Engineering, or related field

9+ years of experience in quality engineering within a regulated industry

Certified Quality Engineer (or working towards)

Tools

SPC

DOE

Six Sigma

Job description

AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.

Every day, your work supports the advancement of medical technology.
NDI is the recognized global leader and industry pioneer of Optical and Electromagnetic tracking technology. Backed by decades of innovation and expertise, we're the strategic partner of choice for the world's top medical device OEMs, advancing the development of OEM navigation platforms. Leading OEM navigation platforms rely on our technologies for accuracy and reliability across demanding applications, and as a strategic partner, we support them from concept through integration to commercialization.

Whether you're designing technology, supporting customers, or enabling the teams behind them, your work matters. Every role at NDI plays a part in shaping the future of medical technology innovation.

Senior Quality Engineering Specialist

POSITION DETAILS:

Job Location: Waterloo

Position Vacancy Type: New Position

Compensation Range: $95,000.00 - $120,000.00 per year

THE 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.


• 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 and 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, thoughtful problem-solving, and a commitment to doing things right, this could be the place for you. We support one another by building strong partnerships across teams and winning together through shared knowledge and diverse perspectives. You'll be surrounded by people who are passionate about what they do, continuously learning, improving with purpose, and driven by work that truly makes a difference.

We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. We do not use artificial intelligence or automated decision-making tools in our recruitment process. All applications are reviewed by our hiring team.NDI is committed to providing an inclusive and accessible recruitment process. Accommodations are available upon request for candidates taking part in all aspects of the selection process. If you require accommodation, please let us know and we will work with you to meet your needs. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.

NDI is proud to be an equal opportunity employer and does not unlawfully discriminate against any employee or applicant on the basis of race, color, religion, sex, place of origin, ancestry, age, ethnic origin, sexual orientation, citizenship, creed, family status, handicap or marital status. We believe in the dignity and worth of all individuals and promote inclusivity and accessibility in how we do business. NDI is committed to minimizing barriers to persons with disabilities. NDI's Statement of Commitment and multi-year accessibility plan is accessible upon request by emailing [e-mail].

Accessibility

At NDI we believe in the dignity and worth of all individuals and promote inclusivity and accessibility in all aspects of how we operate. We are committed to aligning our policies, practices, and procedures with The Accessibility for Ontarians with Disabilities Act, 2005 (AODA) by identifying, removing, and preventing barriers to inclusion for people with disabilities. We continually monitor and evaluate the implementation of NDI's Accessibility Plan and Accessibility Policy, and solicit feedback related to NDI's accessibility initiatives from employees and customers alike.