Medical Device QMS Auditor

BSI; United States; Remote; USD 98,000 - 124,000; Full time

Benefits offered by this job

Health and dental insurance

Disability insurance

401(k) plan

Life insurance

Paid holidays (11)

Paid time off (4 weeks)

Job summary

BSI is seeking a Medical Device QMS Auditor to evaluate quality management systems focusing on design and manufacturing controls for medical devices, SaMDs, and IVDs. This role requires extensive travel to client sites and a strong hands-on background in regulatory compliance.

Candidates should have a technical degree and multiple years of direct device experience, with travel readiness and strong communication skills to lead audit teams and deliver actionable findings.

Qualifications

• Bachelor’s degree in engineering/science required; advanced degrees preferred.
• Hands-on experience with design and manufacturing controls and process validation.
• Knowledge of ISO 13485, MDSAP, FDA QSR (21 CFR 820) and EU MDR/IVDR is a plus.

Responsibilities

• Analyze and assess quality management systems with emphasis on controls and validation to ensure ISO 13485 and MDSAP compliance.
• Assess manufacturing processes, including production controls and risk management.
• Prepare assessment reports with clear corrective actions and communicate findings to clients.
• Lead assessment teams and manage relationships with clients and team members.

Skills

Design controls

Manufacturing controls

Process validation

Regulatory knowledge

Documentation

Education

Bachelor’s degree in Engineering or Science

MS/PhD preferred

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job Title: Medical Device QMS Auditor

Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH.

BSI (British Standards Institution) is the global business standards company that equips businesses with the 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.

This is a travel based position with extensive travel to medical device manufacutering sites. Candidate must be comfortable with overnight travel of 13-15 days out of every month.

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 (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 experience only 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.

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About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.