Medical Device QMS Auditor

Medical Device QMS Auditor

BSI (British Standards Institution) is an accreditation organization and a global business standards company that equips businesses with practical solutions to turn standards of best practice into habits of excellence.

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

• Analyze quality systems and assess ISO 13485, CE Marking, and MDSAP schemes.
• Prepare assessment reports and deliver findings to clients to ensure understanding of decisions and clear direction on corrective actions.
• Recommend the issue, re‑issue, or withdrawal of certificates and report recommendations in accordance with BSI policy, procedures, and prescribed timelines.
• Maintain overall account responsibility and accountability for nominated accounts to ensure effective partnership, excellent service delivery, and account growth.
• Lead assessment teams as required, ensuring team members are briefed to maintain quality of service and effective relationships with clients and within the team.
• Provide accurate and prompt information to support services, working closely with them to keep client records up to date and complete and meet all internal information requirements.
• Coach colleagues, especially inexperienced assessors or those unfamiliar with clients' business/technology, and assist in the induction and coaching of new colleagues as requested.
• Plan and schedule workloads to maximize revenue‑earning activity and efficient use of time.

• Associate’s degree or higher in Engineering, Science, or a related field.
• Minimum of 4 years’ experience in the medical device field, including at least 2 years of hands‑on design, manufacturing, testing, or clinical evaluation.
• Familiarity with BSI systems and processes developed through the qualification process.
• Knowledge of business processes and application of quality management standards.
• Strong verbal and written communication skills and attention to detail.
• Self‑motivated, flexible, and excellent time‑management and planning skills.
• Ability to work under pressure.
• Willingness to travel extensively for business.
• Enthusiastic and committed team player.
• Good public‑speaking and business‑development skills considered advantageous.

Salary range: $98,100 – $123,860 annually. Compensation is based on factors such as competencies, experience, education, location, and internal comparatives. BSI offers a competitive salary, group‑sponsored health and dental, short‑term and long‑term disability, a company‑matched 401(k) plan, company‑paid life insurance, 11 paid holidays, and 4 weeks paid time off.

BSI is a business improvement and standards company that has positively impacted organizations and society for over a century. Today BSI partners with more than 77,500 clients in 195 countries and engages a community of 15,000 experts, industry groups, and governments.

Utilizing extensive expertise in key industry sectors—including automotive, aerospace, built environment, food, retail, and healthcare—BSI helps clients fulfil their promises and accelerate progress toward a better, sustainable world.

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