Medical Device QMS Consultant

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.