Quality Engineer - CAPA, Change Control & Audits Lead

Fresenius Group; Richmond Hill; Ibrido; CAD 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

FME Canada in Richmond Hill seeks a Quality Engineer to manage CAPA, nonconformance, and change control within a regulated medical device environment. You will support Health Canada audits and product release as required, ensuring compliance with Canadian GMP and ISO 13485/14971 standards.

The role is hybrid, with 1–3 days in the office. Ideal candidates have 3–5 years in quality engineering and CQE/CQA certification, plus experience with electronic QMS tools such as QTRAK, Windchill, TrackWise

Competenze

• Bachelor’s degree in engineering, life sciences or a related technical discipline.
• 3–5 years in quality engineering or quality assurance in a regulated medical device or pharmaceutical environment.
• Hands-on ownership of CAPA, nonconformance and change control records, including root cause analysis and effectiveness checks.
• Working knowledge of the Medical Devices Regulations (SOR/98-282), ISO 13485:2016 and ISO 14971.
• Experience with third-party or regulatory audits (MDSAP, ISO 13485, Health Canada or FDA).
• Experience with an electronic QMS (QTRAK, Windchill, TrackWise or MasterControl).
• Strong technical writing skills in English.

Mansioni

• Lead and facilitate CAPAs from initiation through effectiveness check, meeting defined timeliness targets.
• Conduct root cause investigations using structured tools (5 Whys, fishbone, fault tree) and document evidence.
• Apply ISO 14971 risk principles to assess impact and risk level.
• Define measurable effectiveness criteria and perform checks; escalate overdue CAPAs.
• Prepare quality metrics and trend data for site quality reviews and Management Review.
• Initiate, investigate and disposition nonconforming product and process events, including supplier NCs.
• Lead Material Review Board activities, segregation and quarantine, and disposition.
• Trend NCs and escalate recurring/high-risk issues to CAPA.
• Assess whether NC or complaint triggers Health Canada reporting or recall, support post-market vigilance.
• Own change requests from impact assessment through implementation and closure.
• Assess changes for validation, risk, labelling, supplier, training and documentation impact.
• Flag significant changes to regulatory route to Regulatory Affairs.
• Ensure changes are verified as effective before closure.
• Participate in internal and supplier audits, MDSAP surveillance.

Conoscenze

CAPA ownership

Root cause analysis

Regulatory audits

Quality Management System

Technical writing

Formazione

Bachelor's degree in engineering, life sciences or related technical discipline

ASQ CQE or CQA certification; ISO 13485 lead auditor training preferred

Strumenti

QTRAK

Windchill

TrackWise

MasterControl

Descrizione del lavoro

FME Canada in Richmond Hill seeks a Quality Engineer to manage CAPA, nonconformance, and change control within a regulated medical device environment. You will support Health Canada audits and product release as required, ensuring compliance with Canadian GMP and ISO 13485/14971 standards.

The role is hybrid, with 1–3 days in the office. Ideal candidates have 3–5 years in quality engineering and CQE/CQA certification, plus experience with electronic QMS tools such as QTRAK, Windchill, TrackWise