Quality Engineer II

TL;DR

Quality Engineer II (QMS/Medical Devices): Supporting the Quality team with the implementation and maintenance of QMS for medical devices with an accent on FDA 21 CFR Part 820 and ISO 13485 compliance. Focus on supplier and internal QMS audits, supplier corrective action (SCAR/CAPA), scrap reduction, and inspection/quality controls to reduce non-conformances and warranty impact.

Location: Mississauga, ON, Canada

Company

hirify.global is a global technology leader focused on photonic innovation and market-driven solutions for illumination, optical, detection, and imaging needs.

What you will do

• Perform supplier QMS audits, analyze audit observation trends, and manage the supplier QMS audit program.
• Conduct internal QMS audits and regularly communicate with Engineering, Manufacturing Engineering, and Supply Chain to identify quality and productivity improvement opportunities.
• Review supplier manufacturing processes, collaborate on process improvement, and analyze/present supplier performance data.
• Manage the supplier corrective action (SCAR) program and support CAPA, calibration, deviation, and change order processes.
• Advise Quality Inspectors on day-to-day production issues, implement in-process and outgoing inspection programs, and analyze scrap to reduce non-conformances.
• Participate in engineering change/design reviews and support product realization activities including FMEA, using SPC tools to track process stability and capability.

Requirements

• 3–6 years of experience in a Medical Device Quality Assurance environment; hands-on experience with ISO 13485, FDA 21 CFR Part 820, and ISO 14971.
• Solid understanding of root cause analysis and experience managing an effective CAPA program.
• Experience performing and managing both internal and external QMS audits; ISO 13485 internal or lead auditor experience required (ISO 9001 lead auditor desired).
• Ability to interpret technical drawings, schematics, and specification sheets.
• Experience using test equipment (e.g., optical coordinate measuring machine, micrometer, caliper, pin gauges, digital multimeter, power supply, oscilloscope) and knowledge of GD&T/CMM is an asset.
• Excellent English verbal and written communication skills and ability to travel for business purposes.

Culture & Benefits

• Regular full-time role in a global technology organization.
• Work focused on continuous improvement of operations and supplier quality to reduce scrap and warranty impact.
• Collaboration across Quality, Engineering, Manufacturing Engineering, and Supply Chain.
• Compliance-driven environment aligned to ISO 13485 and FDA 21 CFR Part 820.