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Medical Device Assessor Jobs (NOW HIRING)

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Job Title: Medical Device QMS Auditor Location: Candidates must reside in one of the following ... Analyze and assess quality management systems with emphasis on design controls, manufacturing ...

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Location: Delaware Largescale Medical Device client facing a ... Remediation & Implementation • Develop and execute remediation plans following gap assessments ...

Accenture Federal Services

Tech Assessor

Washington, DC · On-site

Conduct and coordinate onsite discovery activities at hospitals and clinics, including assessments ... Familiarity with system interfaces, medical device connectivity, and healthcare IT infrastructure.

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Medical Device Assessor information

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$32.5K

$75.3K

$125.5K

How much do medical device assessor jobs pay per year?

As of Jun 11, 2026, the average yearly pay for medical device assessor in the United States is $75,259.00, according to ZipRecruiter salary data. Most workers in this role earn between $46,000.00 and $97,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Medical Device Assessor position, and why are they important?

A Medical Device Assessor requires a solid background in biomedical engineering, life sciences, or a related field, along with familiarity with regulatory standards such as ISO 13485 and MDR. Proficiency in using risk assessment tools, quality management systems, and technical documentation platforms is important, as well as certifications like RAC (Regulatory Affairs Certification) being advantageous. Attention to detail, analytical thinking, and effective communication are essential soft skills for excelling in this role. These skills are vital to ensure that medical devices meet strict safety, efficacy, and regulatory requirements, protecting patient health and supporting industry compliance.

What is a Medical Device Assessor job?

A Medical Device Assessor evaluates medical devices to ensure they meet regulatory standards for safety, performance, and compliance. They review technical documentation, assess clinical data, and conduct audits to verify adherence to regulations such as ISO 13485 and MDR. Assessors work for regulatory bodies, notified bodies, or consulting firms, helping manufacturers bring safe and effective devices to market. Their role is crucial in protecting public health by ensuring that medical devices perform as intended and pose minimal risk to users.

What are the typical daily responsibilities of a Medical Device Assessor?

As a Medical Device Assessor, your daily tasks often include reviewing technical documentation, assessing conformity to regulatory standards, and preparing detailed reports for manufacturers and regulatory bodies. You may also conduct audits, communicate with product development teams, and stay updated on evolving regulations. Collaboration with cross-functional teams, such as clinical experts and quality assurance professionals, is common to ensure all safety and efficacy criteria are met. The role requires balancing diligence in assessment with clear, actionable feedback to both internal and external stakeholders.

More about Medical Device Assessor jobs
What states have the most Medical Device Assessor jobs? States with the most job openings for Medical Device Assessor jobs include:
What job categories do people searching Medical Device Assessor jobs look for? The top searched job categories for Medical Device Assessor jobs are:
Medical Device Assessor jobs near you
Infographic showing various Medical Device Assessor job openings in the United States as of June 2026, with employment types broken down into 36% Locum Tenens, 4% As Needed, 8% Full Time, 32% Temporary, and 20% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $75,259 per year, or $36.2 per hour.

Medical Device QMS Auditor

BSI Group

Concord, NC • Remote

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Posted 9 days ago

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job Title: Medical Device QMS Auditor

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 manufacutering sites. Candidate 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.

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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.

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