BSI
Medical Device QMS Auditor
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BSI
BSI (British Standards Institution) is a global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
Job Title QMS Auditor
Location Must be located in the US (Minnesota, Wisconsin, or Illinois)
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 or 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 field required.
Minimum of 4 years experience in the medical device field, including at least 2 years of hands‑on medical device design, manufacturing, testing or clinical evaluation experience.
Familiarity with BSI systems and processes as developed 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.
Self‑motivated, flexible, with excellent time management and planning skills.
Ability to work under pressure.
Willingness to travel on business intensively.
Enthusiastic and committed team player.
Good public speaking and business development skills will be considered advantageous.
Salary & 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 401(k) plan, company‑paid life insurance, 11 paid holidays and 4 weeks paid time off.
About BSI BSI is a business improvement and standards company and for over a century 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, retail, and healthcare – BSI delivers on its purpose by helping its clients fulfil theirs.
Living by its 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.
Equal Opportunity Employer BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
#J-18808-Ljbffr
–
BSI
BSI (British Standards Institution) is a global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
Job Title QMS Auditor
Location Must be located in the US (Minnesota, Wisconsin, or Illinois)
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 or 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 field required.
Minimum of 4 years experience in the medical device field, including at least 2 years of hands‑on medical device design, manufacturing, testing or clinical evaluation experience.
Familiarity with BSI systems and processes as developed 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.
Self‑motivated, flexible, with excellent time management and planning skills.
Ability to work under pressure.
Willingness to travel on business intensively.
Enthusiastic and committed team player.
Good public speaking and business development skills will be considered advantageous.
Salary & 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 401(k) plan, company‑paid life insurance, 11 paid holidays and 4 weeks paid time off.
About BSI BSI is a business improvement and standards company and for over a century 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, retail, and healthcare – BSI delivers on its purpose by helping its clients fulfil theirs.
Living by its 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.
Equal Opportunity Employer BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
#J-18808-Ljbffr