Job Overview
Location
Indiana, USA
Job Type
Full-time
Category
Operations Manager
Date Posted
February 22, 2026
Full Job Description
📋 Description
- • Join The British Standards Institution (BSI) as a pivotal QMS Auditor, a role dedicated to ensuring excellence and patient safety within the global medical device industry. As a homebased auditor located in the US, specifically within Minnesota, Wisconsin, or Illinois, you will be instrumental in upholding the highest standards of quality management systems, directly contributing to BSI's mission of creating positive change for people and the planet.
- • In this critical position, you will leverage your expertise to analyze and assess quality management systems against internationally recognized schemes such as ISO 13485, CE Marking requirements, and the Medical Device Single Audit Program (MDSAP). Your thorough evaluations will be the cornerstone of ensuring that medical device manufacturers meet stringent regulatory and quality benchmarks, thereby safeguarding patient well-being and facilitating timely market access for their innovative products.
- • A core responsibility involves the meticulous preparation of comprehensive assessment reports. These reports will not only detail your findings but also clearly communicate the assessment decision to clients. Crucially, you will provide clear, actionable direction for any necessary corrective actions, guiding clients towards achieving and maintaining compliance and excellence.
- • Based on your assessments, you will make informed recommendations regarding the issuance, re-issuance, or withdrawal of certifications. This decision-making process must adhere strictly to BSI's established policies, procedures, and prescribed timeframes, ensuring consistency and integrity in our certification services.
- • You will be entrusted with overall account responsibility and accountability for a portfolio of nominated clients. This involves cultivating and maintaining effective partnerships, ensuring the delivery of exceptional service, and identifying opportunities for account growth. Your proactive engagement will foster strong, collaborative relationships built on trust and mutual understanding.
- • As a leader, you may be required to lead assessment teams. In this capacity, you will ensure that team members are thoroughly briefed, maintaining the highest quality of service delivery. Your leadership will foster effective working relationships, both with clients and within the assessment team, promoting a cohesive and high-performing unit.
- • Providing accurate and prompt information to internal support services is paramount. You will work closely with these teams to ensure that client records are consistently up-to-date and complete, fulfilling all internal information requirements and contributing to the smooth operation of BSI's services.
- • A significant aspect of this role involves mentoring and coaching colleagues. You will provide guidance, particularly to inexperienced assessors or those unfamiliar with specific client business technologies. Your support will also extend to assisting in the induction and coaching of new colleagues, contributing to the development of a skilled and knowledgeable team.
- • Strategic workload planning and scheduling are essential for maximizing your own time efficiency and revenue-earning activities. You will be expected to manage your schedule effectively to meet assessment demands and business objectives.
- • This role demands a deep understanding of business processes and the practical application of quality management standards within the medical device sector. Your ability to translate complex standards into practical, assessable requirements will be key to your success.
- • You will be a self-starter, demonstrating flexibility and excellent time management and planning skills. The ability to work effectively under pressure, meet deadlines, and adapt to changing priorities is crucial.
- • This is a homebased role, but it requires intensive business travel to client sites across the US. Your commitment to travel is essential for conducting on-site assessments and maintaining client relationships.
- • As an enthusiastic and committed team player, you will contribute positively to BSI's collaborative culture. Your dedication to achieving shared goals and supporting your colleagues will be highly valued.
- • While not mandatory, good public speaking and business development skills will be considered advantageous, offering opportunities to represent BSI and contribute to its growth.
- • Ultimately, your work as a QMS Auditor at BSI will directly impact patient safety and the integrity of medical devices available in the market. You will be a guardian of excellence, ensuring that the highest standards are met and that positive change is driven through rigorous assessment and constructive feedback.
🎯 Requirements
- • Associate's degree or higher in Engineering, Science, or a related field.
- • Minimum of 4 years of experience in the medical device field, with at least 2 years of hands-on experience in medical device design, manufacturing, testing, or clinical evaluation.
- • Demonstrated knowledge of business processes and the application of quality management standards (e.g., ISO 13485, CE Marking, MDSAP).
- • Excellent verbal and written communication skills, with a keen eye for detail.
- • Self-motivated, flexible, with excellent time management and planning skills; ability to work under pressure.
🏖️ Benefits
- • Competitive salary ranging from $98,100 to $123,860 annually, based on experience and qualifications.
- • Group-sponsored health and dental insurance.
- • Short-term and long-term disability coverage.
- • Company-matched 401k plan.
- • Company-paid life insurance.
- • 11 paid holidays and 4 weeks of paid time off (PTO) annually.
Skills & Technologies
Go
Remote
Degree Required
About The British Standards Institution
Founded in 1901, The British Standards Institution (BSI) is the United Kingdom's national standards body. It develops and publishes technical standards and certification services across quality, safety, risk, and sustainability. BSI offers testing, inspection, training, and supply-chain compliance solutions to help organizations meet regulatory and industry requirements worldwide.
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