Archived listing. The details below describe a past opening.
Position Title: Quality Management System (QMS) Specialist
Location: Greater Montreal Area / Ottawa Region (Hybrid)
Employment Type: Full-Time / Permanent
Work Model: Hybrid Remote (Occasional onsite visits required based on client and project needs)
Eligibility Requirement: Must be a Permanent Resident or Canadian Citizen residing in Canada
About the Role
We are seeking a detail-oriented, highly organized, and experienced Quality Management System (QMS) Specialist to join our team in the Montreal/Ottawa corridor. In this role, you will play a critical part in helping organizations establish, maintain, and continuously improve their quality management systems in compliance with international standards and global regulatory frameworks. Operating in a versatile capacity, you will frequently act as a fractional Quality Manager for medical device and life science clients, establishing robust documentation systems, overseeing CAPA/NCR processes, and leading internal audits.
Key Responsibilities & Tasks1. Fractional Quality Management & Advisory
- Act as a fractional/interim Quality Manager for partner client organizations, overseeing daily QMS execution and maintaining quality compliance.
- Serve as the primary liaison for regulatory authorities, notified bodies, and third-party auditors during external audits.
- Monitor QMS key performance indicators (KPIs) and report on quality metrics to senior leadership and client management teams.
2. Documentation Systems & Document Control
- Implement, configure, and maintain compliant Document Control and Quality Management Systems (eQMS / manual systems).
- Draft, review, and manage Quality Manuals, Standard Operating Procedures (SOPs), Work Instructions (WIs), and Form Templates.
- Ensure strict document change control processes, proper version history, and document archiving compliance.
3. Quality Process Execution (CAPA, NCR, Change Control)
- Lead Non-Conformance Reports (NCR) and Corrective and Preventive Action (CAPA) investigations, perform root cause analyses, and track actions through to successful closure and effectiveness check.
- Oversee customer complaints, post-market surveillance data, and medical device reporting requirements.
- Manage formal change control requests for process, product, and documentation revisions.
4. Internal Auditing & Quality Training
- Plan, schedule, conduct, and report on internal QMS audits to ensure ongoing compliance with applicable standards and regulations.
- Evaluate supplier quality, including performing supplier audits and establishing quality agreements.
- Develop and deliver training programs on QMS principles, SOPs, ISO standards, and regulatory requirements for cross-functional teams.
Qualifications & RequirementsExperience & Legal Status
● Experience: Minimum of 2 years of direct experience implementing and managing Quality Management Systems (QMS).
● Location: Based in the Greater Montreal Area or Ottawa Region, with the flexibility to travel on-site as required.
Language Skills
● Bilingualism: Full professional proficiency in both English and French (written and spoken) is required to support stakeholders across Quebec, Ontario, and international markets.
Technical & Regulatory Knowledge
- In-depth knowledge of quality management standards and medical device regulatory frameworks:
○ ISO 13485:2016 (Medical Devices – Quality Management Systems)
○ ISO 9001:2015 (Quality Management Systems)
○ MDSAP (Medical Device Single Audit Program)
○ EU MDR (Regulation (EU) 2017/745)
○ EU IVDR (Regulation (EU) 2017/746)
- Strong understanding of risk management concepts (ISO 14971) and continuous improvement methodologies.
- Lead Auditor or Internal Auditor certification (e.g., ISO 13485 / ISO 9001) is considered a strong asset.
Key Competencies
● Problem Solving: Strong analytical skills with demonstrated experience in root cause analysis methodologies (5 Whys, Fishbone diagram).
● Communication: Exceptional interpersonal and business communication skills in both English and French.
● Adaptability: Ability to balance multiple priorities and adapt seamlessly when supporting multiple client environments as a fractional Quality Manager.
● Attention to Detail: Rigorous standard for accuracy in documentation, audit reporting, and regulatory submissions.
