Medical Device QMS Auditor

BSI · United States

Hybrid
Full-time
$110,000 / year
United States

Job highlights

Audit medical device quality systems globally.
Ensure compliance with ISO 13485, CE, MDSAP.
Requires technical degree and 4+ years experience.
Extensive travel, 13-15 days per month.
Competitive salary and benefits package.

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!

Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH.

BSI (British Standards Institution) is the global business standards company that equips businesses with the 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.

This is a travel-based position with extensive travel to medical device manufacturing sites. Candidates must be comfortable with overnight travel of 13-15 days out of every month.

Essential Responsibilities

Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications

Technical degree (Bachelor’s, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
Minimum of 4 years’ experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit experience only is insufficient.
Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR are a plus.

Core Competencies

Strong verbal and written communication skills, and attention to detail.
Ability to work under pressure and meet deadlines.
Self-motivated, flexible, and excellent time management/planning skills.
Willingness to travel extensively.
Enthusiastic, committed team player.
Business development and public speaking skills are considered advantageous.

Preferred Qualifications

Experience with process validation, equipment qualification, and manufacturing process development.
Experience in design and development activities, including design controls and design transfer.
Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
Experience leading hands-on teams in manufacturing, testing, or validation.
Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

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 QMS Auditor
ISO 13485
MDSAP
CE Marking
FDA QSR
EU MDR/IVDR
Risk Management
Process Validation
Design Controls
Manufacturing Controls

Skills & topics

Medical Device Auditor
QMS Auditor
ISO 13485
MDSAP
FDA QSR
EU MDR
IVDR
Quality Management
Medical Device Manufacturing
Regulatory Compliance
Auditing
Engineering
Science
Risk Management
Process Validation
Design Controls
Travel
Healthcare

How to get hired

Tailor your resume: Highlight your hands-on experience with medical device design, manufacturing, validation, and specific QMS standards like ISO 13485 and MDSAP. Emphasize your technical degree and 4+ years of direct involvement.
Showcase relevant skills: In your application and resume, detail your experience with process validation (IQ/OQ/PQ), risk management (ISO 14971), design controls, and supplier controls. Mention any experience with FDA QSR or EU MDR/IVDR.
Demonstrate travel readiness: Clearly state your willingness and ability to travel extensively, up to 13-15 days per month, as this is a core requirement for the Medical Device QMS Auditor role.
Prepare for technical interviews: Be ready to discuss specific scenarios related to auditing manufacturing processes, design controls, and regulatory compliance. Practice explaining complex technical details clearly and concisely.
Research BSI's impact: Understand BSI's mission to create positive change and their role in global standards. Align your own career aspirations with their values of Client-Centricity, Agility, and Collaboration.

Technical preparation

Master ISO 13485, MDSAP, FDA QSR, EU MDR/IVDR.,Review design controls and manufacturing processes.,Understand risk management (ISO 14971).,Prepare for process validation (IQ/OQ/PQ) discussions.

Behavioral questions

Describe a complex audit scenario.,How do you handle client disagreements?,How do you manage extensive travel?,Explain your attention to detail.

Frequently asked questions

What specific states are candidates for the Medical Device QMS Auditor role required to reside in?: For the Medical Device QMS Auditor position at BSI, candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, or OH.
What is the expected travel frequency for the Medical Device QMS Auditor position at BSI?: The Medical Device QMS Auditor role is a travel-based position requiring candidates to be comfortable with extensive overnight travel, approximately 13-15 days out of every month, visiting medical device manufacturing sites.
What are the minimum educational and experience requirements for the Medical Device QMS Auditor role?: Candidates for the Medical Device QMS Auditor role must possess a technical degree (Bachelor's or higher) in Engineering or Science. Additionally, a minimum of 4 years of direct, hands-on experience in the medical device field (design, manufacturing, validation, etc.) is required; regulatory or audit experience alone is insufficient.
Which quality management standards and regulatory requirements are most important for a Medical Device QMS Auditor at BSI?: Key standards and regulations for the Medical Device QMS Auditor include ISO 13485, CE Marking, and MDSAP schemes. Knowledge of FDA QSR (21 CFR 820) and EU MDR/IVDR is also highly beneficial.
Does BSI offer remote work options for the Medical Device QMS Auditor position?: No, the Medical Device QMS Auditor position is a travel-based role requiring extensive on-site assessment at client facilities. While the candidate must reside in specific states for logistical reasons, the role itself involves significant travel and is not remote.
What specific types of hands-on experience are crucial for the Medical Device QMS Auditor role?: Crucial hands-on experience for this role includes detailed involvement with design and manufacturing/production controls, process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control within the medical device industry.
What is the salary range for the Medical Device QMS Auditor position at BSI?: The annual salary range for the Medical Device QMS Auditor position at BSI is between $98,100 and $123,860, with the final compensation determined by factors such as experience, education, and location.
Are there any preferred qualifications for the Medical Device QMS Auditor role at BSI?: Preferred qualifications include experience with process validation, equipment qualification, manufacturing process development, design and development activities, software-controlled medical devices, auditing QMS, risk management (ISO 14971), and Lead Auditor certification. Experience working for a Notified Body or Certification Body is also advantageous.

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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!

Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH.

This is a travel-based position with extensive travel to medical device manufacturing sites. Candidates must be comfortable with overnight travel of 13-15 days out of every month.

Essential Responsibilities

Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications

Technical degree (Bachelor’s, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
Minimum of 4 years’ experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit experience only is insufficient.
Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR are a plus.

Core Competencies

Strong verbal and written communication skills, and attention to detail.
Ability to work under pressure and meet deadlines.
Self-motivated, flexible, and excellent time management/planning skills.
Willingness to travel extensively.
Enthusiastic, committed team player.
Business development and public speaking skills are considered advantageous.

Preferred Qualifications

Experience with process validation, equipment qualification, and manufacturing process development.
Experience in design and development activities, including design controls and design transfer.
Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
Experience leading hands-on teams in manufacturing, testing, or validation.
Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

About Us

Key skills/competency

Medical Device QMS Auditor
ISO 13485
MDSAP
CE Marking
FDA QSR
EU MDR/IVDR
Risk Management
Process Validation
Design Controls
Manufacturing Controls

How to get hired

Tailor your resume: Highlight your hands-on experience with medical device design, manufacturing, validation, and specific QMS standards like ISO 13485 and MDSAP. Emphasize your technical degree and 4+ years of direct involvement.
Showcase relevant skills: In your application and resume, detail your experience with process validation (IQ/OQ/PQ), risk management (ISO 14971), design controls, and supplier controls. Mention any experience with FDA QSR or EU MDR/IVDR.
Demonstrate travel readiness: Clearly state your willingness and ability to travel extensively, up to 13-15 days per month, as this is a core requirement for the Medical Device QMS Auditor role.
Prepare for technical interviews: Be ready to discuss specific scenarios related to auditing manufacturing processes, design controls, and regulatory compliance. Practice explaining complex technical details clearly and concisely.
Research BSI's impact: Understand BSI's mission to create positive change and their role in global standards. Align your own career aspirations with their values of Client-Centricity, Agility, and Collaboration.

Frequently asked questions

What specific states are candidates for the Medical Device QMS Auditor role required to reside in?

For the Medical Device QMS Auditor position at BSI, candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, or OH.

What is the expected travel frequency for the Medical Device QMS Auditor position at BSI?

The Medical Device QMS Auditor role is a travel-based position requiring candidates to be comfortable with extensive overnight travel, approximately 13-15 days out of every month, visiting medical device manufacturing sites.

What are the minimum educational and experience requirements for the Medical Device QMS Auditor role?

Candidates for the Medical Device QMS Auditor role must possess a technical degree (Bachelor's or higher) in Engineering or Science. Additionally, a minimum of 4 years of direct, hands-on experience in the medical device field (design, manufacturing, validation, etc.) is required; regulatory or audit experience alone is insufficient.

Which quality management standards and regulatory requirements are most important for a Medical Device QMS Auditor at BSI?

Key standards and regulations for the Medical Device QMS Auditor include ISO 13485, CE Marking, and MDSAP schemes. Knowledge of FDA QSR (21 CFR 820) and EU MDR/IVDR is also highly beneficial.

Does BSI offer remote work options for the Medical Device QMS Auditor position?

No, the Medical Device QMS Auditor position is a travel-based role requiring extensive on-site assessment at client facilities. While the candidate must reside in specific states for logistical reasons, the role itself involves significant travel and is not remote.

What specific types of hands-on experience are crucial for the Medical Device QMS Auditor role?

Crucial hands-on experience for this role includes detailed involvement with design and manufacturing/production controls, process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control within the medical device industry.

What is the salary range for the Medical Device QMS Auditor position at BSI?

The annual salary range for the Medical Device QMS Auditor position at BSI is between $98,100 and $123,860, with the final compensation determined by factors such as experience, education, and location.

Are there any preferred qualifications for the Medical Device QMS Auditor role at BSI?

Preferred qualifications include experience with process validation, equipment qualification, manufacturing process development, design and development activities, software-controlled medical devices, auditing QMS, risk management (ISO 14971), and Lead Auditor certification. Experience working for a Notified Body or Certification Body is also advantageous.