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

Seratos Consulting Inc.; Montreal; Hybrid; CAD 30,000 - 45,000; Part time

Job summary

A leading consulting firm in Montreal is seeking a Document Control and Quality Support Consultant to assist in managing quality documents and ensuring compliance with ISO standards. This part-time role involves working closely with consulting teams on various projects in the medical device industry, requiring strong organizational skills and bilingual proficiency in French and English.

Qualifications

• Degree in life sciences, biomedical engineering, or related field required.
• Basic knowledge of ISO 9001:2015, 13485:2016, and MDSAP requirements.
• Experience in quality document management is an asset.

Responsibilities

• Organize, review, and update quality documents for ISO compliance.
• Collaborate on deliverables for quality and regulatory projects.
• Assist in developing training materials and conducting workshops.

Skills

Organizational skills

Attention to detail

Bilingual (French and English)

Education

Degree in life sciences, biomedical engineering, or related field

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.

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Quality Control • Montreal, Montreal (administrative region), Canada