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Medical Device QMS Auditor

The British Standards Institution

Job Overview

Location

Oregon, USA

Job Type

Full-time

Full Job Description

📋 Description

• Be the guardian of patient safety and the catalyst for medical-device market access across the globe. As a Medical Device QMS Auditor you will lead high-stakes assessments of quality-management systems against ISO 13485, CE Marking and MDSAP schemes, directly influencing whether life-saving technologies reach clinicians and patients on time.
• Own the full audit lifecycle—from meticulous planning and on-site or remote assessments to the issuance of clear, actionable reports. You will analyze design controls, risk management, supplier controls, CAPA, post-market surveillance and clinical data, translating complex findings into concise recommendations that clients can implement with confidence.
• Recommend the issue, re-issue or withdrawal of certificates, ensuring every decision aligns with BSI policy, regulatory requirements and patient-safety imperatives. Your signature on a certificate can open—or protect—entire markets.
• Serve as the primary relationship owner for a portfolio of key accounts across Minnesota, Wisconsin and Illinois. You will cultivate strategic partnerships, identify upsell opportunities and ensure service delivery excellence, turning one-off audits into long-term engagements that drive revenue growth.
• Lead and mentor multi-disciplinary audit teams, briefing engineers, microbiologists and regulatory specialists so that every engagement meets BSI’s exacting standards. You will coach junior auditors, share technical insights and foster a culture of continuous learning.
• Collaborate with internal support services to maintain pristine client records, accurate scheduling and timely invoicing. Your attention to detail ensures seamless operations and a friction-free client experience.
• Plan and optimize your own calendar to maximize billable days while balancing travel intensity—up to 75 % across North America—and personal development. You will leverage BSI’s digital tools to forecast workload, avoid conflicts and exceed utilization targets.
• Contribute to business development by presenting at industry conferences, hosting webinars and authoring thought-leadership pieces. Your public-speaking skills will position BSI as the go-to partner for regulatory compliance and quality excellence.
• Stay ahead of evolving regulations—EU MDR, FDA shifts, Health Canada updates—and translate emerging requirements into practical guidance for clients. You will be their trusted navigator in a rapidly changing landscape.
• Champion BSI’s purpose: embedding excellence into organizational DNA so that every device you touch enhances patient outcomes and builds societal trust in healthcare technology.

🎯 Requirements

• Associate’s degree or higher in Engineering, Science or related technical discipline
• Minimum 4 years in the medical-device sector, including at least 2 years of hands-on experience in design, manufacturing, testing or clinical evaluation of devices
• Demonstrated knowledge of ISO 13485, CE Marking and/or MDSAP requirements
• Strong written and verbal communication skills with an eye for detail and the ability to convey complex findings to diverse audiences
• Self-motivated, flexible and able to manage intensive travel schedules (up to 75 %) while maintaining high performance

🏖️ Benefits

• Competitive base salary ranging from $98,100 to $123,860, commensurate with experience and location
• Comprehensive benefits package: group-sponsored health and dental, short- and long-term disability, company-matched 401(k) and company-paid life insurance
• 4 weeks paid time off plus 11 paid holidays to support work-life balance
• Fully remote, home-based role with cutting-edge digital tools and a supportive, collaborative culture

Skills & Technologies

Remote

Degree Required

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The British Standards Institution

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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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