PURPOSE AND SCOPE:
Supports FME Canada’s mission, vision, core values and customer service philosophy. Adheres to the FME Canada Compliance Program, including following all regulatory and division/company policy requirements.
Reporting to the Head of Quality, the Quality Engineer is responsible for day-to-day execution of the CAPA, nonconformance (NC) and change control processes at the Richmond Hill site. The role supports internal, MDSAP and Health Canada audits and performs product release when required. All work must comply with Canadian medical device and, where applicable, drug GMP requirements, while staying aligned with the North America and Global QMS.
DUTIES / ACTIVITIES:
CUSTOMER SERVICE:
• Responsible for driving the FME Canada culture through values and customer service standards.
• Accountable for outstanding customer service to all external and internal customers.
• Develops and maintains effective relationships through effective and timely communication.
• Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.
PRINCIPAL RESPONSIBILITIES AND DUTIES:
• Lead and facilitate CAPAs from initiation through effectiveness check, meeting defined timeliness targets for initiation, impact and risk assessment, and action implementation.
• Run root cause investigations using structured tools (5 Whys, fishbone, fault tree, is/is-not) and document objective evidence.
• Apply ISO 14971 risk principles to assess impact, risk level and the need for field action.
• Define measurable effectiveness criteria and perform effectiveness checks; escalate ineffective or overdue CAPAs.
• Prepare quality metrics (e.g. CAPA, audit, complaint) and trend data for site quality reviews and Management Review.
• Initiate, investigate and disposition nonconforming product and process events, including supplier and distribution NCs.
• Lead Material Review Board activities, segregation and quarantine, and disposition (use-as-is, return to supplier, scrap).
• Trend NCs and escalate recurring or high-risk issues to CAPA.
• Assess whether an NC or complaint triggers Health Canada mandatory problem reporting or a recall and support post market vigilance or product safety in filing.
• Own change requests from impact assessment through implementation and closure.
• Assess changes for validation, risk, labelling, supplier, training and documentation impact.
• Flag changes that may be significant changes requiring a medical device licence or drug dossier amendment, and route them to Regulatory Affairs.
• Ensure changes are verified as effective before closure.
-Participate in internal audits, supplier audits and MDSAP surveillance and recertification audits.
• Support Health Canada establishment licence inspections, including front room / back room roles and document retrieval.
• Prepare for audits through mock audits, storyboards for open CAPAs, record reviews and SME preparation.
• Draft audit finding responses and track resulting CAPAs to on-time closure.
• Perform batch record and documentation review and release or reject product per site procedures, once trained and delegated.
• Verify distribution and traceability records are complete and accurate for released product.
• For drug products, perform release activities only as delegated by the Quality Control Department under GMP requirements.
• Author and revise SOPs, work instructions and forms.
• Support harmonization of Canadian site processes with the North America and Global QMS and eQMS tools.
• Train site personnel on CAPA, NC and change control processes.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- Hybrid position requiring a minimum of 1-3 days/week in the office at the discretion of the manager.
- Maximum 5-10 travel days per year (audits, conferences and meetings).
EDUCATION
- Bachelor's degree in engineering, life sciences or a related technical discipline.
- ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA); ISO 13485 lead auditor training is preferred.
EXPERIENCE AND REQUIRED SKILLS:
Required:
• 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 participating in third-party or regulatory audits (MDSAP, ISO 13485, Health Canada or FDA).
• Experience with an electronic QMS (for example QTRAK, Windchill, TrackWise or MasterControl).
• Strong technical writing skills in English.
Preferred
• Experience with MDSAP audits and Health Canada establishment license inspections.
• Drug GMP experience under Part C, Division 2, including batch record review and release.
• Experience with renal, dialysis or other life-sustaining therapy products.
• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA); ISO 13485 lead auditor training.
• Working proficiency in French.
Core competencies
• Investigative rigour: gets to verified root cause, not the first plausible one.
• Risk-based judgement: sizes the response to patient and compliance risk and knows when to escalate.
• Audit presence: explains records clearly and calmly to auditors and inspectors.
• Ownership of timelines: drives records to on-time closure and raises slippage early.
• Collaboration: works across Operations, Regulatory Affairs, Supply Chain and NA Corporate Quality.
• Data literacy: builds and reads CAPA and NC trend metrics to spot systemic issues.
Relationships
Internal Contacts: Sales and Marketing, Product Safety, Post market Vigilance, Regulatory Affairs, Supply Chain and NA Corporate Quality
External Contacts: Health Canada, Vendors, Medtech Association Staff and Members
SUPERVISION:
N/A
The duties listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
