Job Title: Medical Device QMS Auditor Location: ColoradoOur 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.
This is a travel-based position requiring extensive travel to medical device manufacturing sites, including approximately 13-15 overnight travel days per month. Purpose of role: to conduct various types of audits and work closely with clients to help them improve their performance by assessing their systems and processes against BSI standards.Essential 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.
Education & Technical Qualifications- Technical degree (Associate's, Bachelor's, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
- 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. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit only experience is insufficient.
- 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.
Core Competencies- 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.
- Lead 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.
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.
