Medical Device QMS Auditor- Minnesota / Illinois / Wisconsin

BSI; Chicago (IL); Remote; USD 90,000 - 124,000; Full time

Job summary

An established industry player is seeking a dedicated professional to join their Medical Devices team. This role focuses on ensuring patient safety and supporting market access for medical device products. The ideal candidate will analyze quality systems, prepare assessment reports, and lead teams to maintain high service standards. With a competitive salary and comprehensive benefits, this position offers a unique opportunity to contribute to excellence in the medical field while working in a collaborative environment. If you are passionate about quality and eager to make a difference, this role is perfect for you.

Benefits

Group-sponsored health and dental

Short-term and long-term disability

401k plan with company match

Company paid life insurance

11 paid holidays

4 weeks paid time off

Qualifications

• 4+ years in medical device field with hands-on experience required.
• Strong knowledge of quality management standards and processes.

Responsibilities

• Analyze quality systems and assess ISO 13485 and CE Marking schemes.
• Prepare reports and deliver findings to clients for corrective actions.
• Lead assessment teams and maintain client relationships.

Skills

ISO 13485

CE Marking

MDSAP schemes

Quality management standards

Medical device design

Verbal communication

Written communication

Public speaking

Business development

Time management

Education

Associate's degree or higher in Engineering or Science

Job description

Great that you're thinking about a career with BSI!

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. The successful candidate must be located in Minnesota and must be able to travel at least 40%-60% of the time.

• 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.

The salary for this position can range from $90,100 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.

LI-REMOTE

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Our Excellence Behaviours : Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is an Equal Opportunity Employer and we are committed to diversity.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.