Medical Device QMS Auditor
BSI · United States
- Hybrid
- Full-time
- $110,000 / year
- United States
Job highlights
- Audit medical device quality systems against standards.
- Assess ISO 13485, CE Marking, and MDSAP schemes.
- Prepare and deliver assessment reports to clients.
- Lead assessment teams and coach colleagues.
- Requires medical device experience and travel.
About the role
Medical Device QMS Auditor
We exist to create positive change for people and the planet. Join us and make a difference too! Do you believe the world deserves excellence? BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary 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.
Essential Responsibilities
- Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Maintain overall account responsibility and accountability for nominated accounts to ensure an effective partnership, whilst ensuring excellent service delivery and account growth.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Plan/schedule workloads to make best use of own time and maximize revenue-earning activity.
Education/Qualifications
- Associate's degree or higher in Engineering, Science or related degree required.
- Minimum of 4 years experience in the medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience.
- The candidate will develop familiarity with BSI systems and processes as they go through the qualification process.
- Knowledge of business processes and application of quality management standards.
- Good verbal and written communication skills and an eye for detail.
- Be self-motivated, flexible, and have excellent time management/planning skills.
- Can work under pressure.
- Willing to travel on business intensively.
- An enthusiastic and committed team player.
- Good public speaking and business development skill will be considered advantageous.
Compensation and Benefits
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.
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.
Key skills/competency
- Medical Device Quality Management Systems
- ISO 13485 Auditing
- CE Marking Assessment
- MDSAP Schemes
- Regulatory Compliance
- Risk Management
- Client Relationship Management
- Assessment Reporting
- Team Leadership
- Medical Device Design and Manufacturing
Skills & topics
- Medical Device Auditor
- QMS
- ISO 13485
- CE Marking
- MDSAP
- Regulatory Affairs
- Quality Assurance
- Medical Devices
- Auditing
- BSI
How to get hired
- Tailor your resume: Highlight your medical device QMS experience and ISO 13485, CE Marking, and MDSAP knowledge.
- Showcase relevant experience: Emphasize your 4+ years in the medical device field, including hands-on design or manufacturing.
- Demonstrate key skills: Detail your strong communication, analytical, self-motivation, and time management abilities.
- Express willingness to travel: Clearly state your flexibility for intensive business travel.
- Prepare for interviews: Be ready to discuss your experience with quality management standards and business processes.
Technical preparation
Behavioral questions
Frequently asked questions
- What is the salary range for a Medical Device QMS Auditor at BSI?
- The salary for this Medical Device QMS Auditor position at BSI ranges from $98,100 to $123,860 annually. The final compensation will depend on factors such as your experience, education, and location.
- What qualifications are required for the Medical Device QMS Auditor role at BSI?
- To be considered for the Medical Device QMS Auditor role at BSI, you need an Associate's degree or higher in Engineering, Science, or a related field. You also need at least 4 years of experience in the medical device industry, with a minimum of 2 years of hands-on experience in design, manufacturing, testing, or clinical evaluation.
- Does the Medical Device QMS Auditor position at BSI require travel?
- Yes, the Medical Device QMS Auditor position at BSI requires intensive business travel. Candidates should be willing and able to travel extensively for this role.
- What are the main responsibilities of a Medical Device QMS Auditor at BSI?
- The main responsibilities include analyzing quality systems against ISO 13485, CE Marking, and MDSAP schemes, preparing assessment reports, recommending certificate actions, managing client accounts, leading assessment teams, and coaching colleagues. You will also plan your workload to maximize revenue-earning activity.
- What benefits does BSI offer to a Medical Device QMS Auditor?
- BSI offers a competitive salary, group-sponsored health and dental insurance, short-term and long-term disability, a company-matched 401k plan, company-paid life insurance, 11 paid holidays, and 4 weeks of paid time off.
- How does BSI ensure patient safety with its Medical Devices team?
- BSI's Medical Devices team ensures patient safety by rigorously auditing quality systems and assessing compliance with global standards like ISO 13485, CE Marking, and MDSAP, thereby supporting timely market access for medical device products.
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