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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.

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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.