Document Control and Quality Support Consultant (ISO 9001, ISO 13485)

Seratos Consulting Inc.; Montreal; On-site; CAD 30,000 - 60,000; Part time

Job summary

An established industry player is seeking a Document Control and Quality Support Consultant to enhance quality management in the medical device sector. This part-time role offers a unique opportunity to work with a dynamic consulting team, focusing on organizing and managing essential quality documents while ensuring compliance with ISO standards. The ideal candidate will possess a strong background in life sciences or biomedical engineering, excellent bilingual communication skills, and a keen eye for detail. Join a forward-thinking company that values quality and regulatory excellence, and contribute to impactful projects that shape the future of healthcare.

Qualifications

• Degree in life sciences or biomedical engineering required.
• Knowledge of ISO 9001:2015 and 13485:2016 is essential.

Responsibilities

• Organize, manage, and update quality documents for compliance.
• Collaborate on deliverables for quality and regulatory projects.

Skills

Organizational Skills

Attention to Detail

Bilingual (French and English)

Document Management

Education

Degree in Life Sciences

Biomedical Engineering

Tools

Microsoft Office

Job description

Document Control and Quality Support Consultant (ISO 9001, ISO 13485)

Management Consulting Part Time Montreal, QC Hybrid

As a consultant specializing in document control, you will work closely with the consulting team to support the management of quality documents related to ongoing projects in the medical device industry. Your main responsibilities will involve organizing, managing, and updating quality documents while providing support for ISO 13485:2016 and MDSAP compliance projects.

Main Responsibilities:

Document Control:

· Organize, review, and update quality documents (procedures, forms, manuals, etc.).

· Ensure documents comply with ISO 9001:2015 & ISO 13485:2016 requirements.

· Manage version control and document archiving within quality management systems.

Support for Ongoing Projects:

• Collaborate with consultants to finalize deliverables for quality and regulatory projects.
• Assist in preparing internal audits and reviewing required documentation.
• Contribute to updating and structuring internal quality reports for clients.

Training and Awareness:

• Assist in developing training materials and conducting workshops for clients.
• Participate in raising client teams' awareness of regulatory requirements and quality best practices.

Administrative Support and Communication:

• Maintain up-to-date project reports and records.
• Communicate regularly with clients to ensure the progress of activities and deliverables.

Job Requirements

• Degree in life sciences, biomedical engineering, or a related field.
• Basic knowledge of ISO 9001:2015, 13485:2016 and MDSAP requirements.
• Knowledge of Microsoft Office tools
• Experience in quality document management is an asset.
• Strong organizational skills and attention to detail.
• Excellent command of French and English, both spoken and written.
• Ability to work independently and as part of a team.

Job Type

• Part time (15-20 hours per week) with possible full time.
• Remote work with the option of working from the Montreal office.