Medical Device QMS Auditor

BSI; Toronto; On-site; CAD 100,000 - 125,000; Full time

Job summary

An established industry player in the medical device sector is seeking a dedicated professional to join their Regulatory Services team. This role focuses on ensuring patient safety and facilitating market access for medical devices. The ideal candidate will have substantial experience in the medical device field, particularly in design and manufacturing, along with strong communication skills and the ability to work under pressure. This position offers the chance to make a significant impact in a dynamic environment, where your expertise will help uphold the highest standards of quality and safety in healthcare. If you're passionate about excellence and ready to contribute to a team committed to making a difference, this opportunity is perfect for you.

Qualifications

• 4+ years in medical devices with 2+ years in design, manufacturing, or evaluation.
• Bilingual in French and English is a must for this role.

Responsibilities

• Analyze quality systems and assess ISO 13485 and CE Marking schemes.
• Lead assessment teams and maintain account responsibility for clients.

Skills

Verbal and written communication skills

Time management skills

Public speaking

Business development skills

Bilingual in French and English

Education

4 years experience in medical device field

Hands-on experience in medical device design

Knowledge of quality management standards

Job description

Great that you're thinking about a career with BSI!

Do you believe the world deserves excellence?

BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.

Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.

Essential Responsibilities:

• Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
• Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
• Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
• Maintain overall account responsibility and accountability for nominated accounts to ensure an effective partnership, whilst ensuring excellent service delivery and account growth.
• Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team.
• Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
• Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
• Plan/schedule workloads to make best use of own time and maximize revenue-earning activity.

Education/Qualifications:

• Must be located in Ontario, Canada.
• Minimum of 4 years experience in the medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience in active, plastics or metal medical devices.
• The candidate will develop familiarity with BSI systems and processes as they go through the qualification process.
• Knowledge of business processes and application of quality management standards.
• Good verbal and written communication skills and an eye for detail.
• Be self-motivated, flexible, and have excellent time management/planning skills.
• Can work under pressure.
• Willing to travel on business intensively 50-70% of the time.
• An enthusiastic and committed team player.
• Good public speaking and business development skill will be considered advantageous.
• Must be bilingual in French and English.

If interested in this role, please submit your CV in English.