Senior Quality Engineering Specialist

POSITION DETAILS:

Job Location:Waterloo

Position Vacancy Type:New Position

Compensation Range: $95000.00 - $120000.00 per year

THE IMPACT YOULL 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 teamsdriving design quality leading investigations and ensuring compliance with ISO 13485 FDA QSR and global regulatory requirements.

HOW YOULL 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:

• Bachelors 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.