Medical Device QMS Auditor

About the role

BSI (British Standards Institution) is a global business standards company that ensures patient safety and supports timely market access for medical device products globally. This is a travel-based position requiring extensive travel to manufacturing sites.

Responsibilities

• Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
• Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
• Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
• Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
• Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Requirements

• Technical degree (Bachelor’s, or higher) in Engineering, Science, or a related technical discipline required.
• Minimum of 4 years’ experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices.
• Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
• Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR are a plus.

Qualifications

• Strong verbal and written communication skills, and attention to detail.
• Ability to work under pressure and meet deadlines.
• Self-motivated, flexible, and excellent time management/planning skills.
• Willingness to travel extensively.
• Enthusiastic, committed team player.
• Business development and public speaking skills are considered advantageous.

Preferred Qualifications

• Experience with process validation, equipment qualification, and manufacturing process development.
• Experience in design and development activities, including design controls and design transfer.
• Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
• Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
• Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
• Experience leading hands-on teams in manufacturing, testing, or validation.
• Led Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
• Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
• Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

Benefits

The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate’s competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.