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Contract Medical Device Auditor Jobs (NOW HIRING)

SGS

Contract Opportunity - Medical Device Auditors

The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. * Perform audits for clients' medical device ...

BSI Prof Serv EHS West

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by ...

BSI Group

As a Medical Device Auditor, you'll travel to medical device manufacturers across Europe, Middle East and Africa and occasionally USA. You'll help these manufacturers to improve their performance by ...

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

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 ...

BSI Prof Serv EHS West

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

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 ...

System One

Medical Device Assembler

Lakewood, NJ · On-site

$16/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Contract To Hire Compensation: $16.00 / hr. Contractor Work Model: Onsite Hours: 7:00 AM-3:00 PM Monday-Friday Medical Device Assembler Responsibilities: * Use various machinery to assemble medical ...

Astrix Inc

Medical Device Assembler

Trumbull, CT · On-site

$17.75 - $21.50/hr

  • Medical

  • Dental

Mon-Thu 3:45pm-2:15am Type of Job : 3-6 Month Contract w/ Potential to convert permanently Location : Trumbull, CT Benefits Offered: * Medical/dental coverage! * Weekly pay! Medical Device Assembler ...

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How much do contract medical device auditor jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for contract medical device auditor in the United States is $21.62, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $27.40 per hour, depending on experience, location, and employer.

What is a contract medical device auditor?

Contract Medical Device Auditors are professionals who are hired on a contractual basis to assess and evaluate medical device companies for compliance with regulatory standards such as ISO 13485, FDA regulations, and other applicable quality management systems. They conduct audits, prepare reports, and help organizations identify areas for improvement to ensure the safety and effectiveness of medical devices. These auditors often work independently or through consulting firms, traveling to different manufacturers to perform assessments.

How does a contract medical device auditor typically collaborate with client teams during an audit?

As a Contract Medical Device Auditor, you work closely with client teams throughout the audit process. This includes conducting opening and closing meetings, interviewing staff, and reviewing documentation to ensure compliance with regulatory standards such as ISO 13485 or FDA requirements. Effective communication and professionalism are essential, as the auditor often needs to explain findings, answer questions, and provide guidance on corrective actions. Building a collaborative relationship helps ensure audits are thorough, constructive, and support continuous improvement for the client.

What are the key skills and qualifications needed to thrive as a contract medical device auditor, and why are they important?

To thrive as a Contract Medical Device Auditor, you need a strong understanding of quality management systems, regulatory standards (such as ISO 13485), and experience in medical device manufacturing or compliance, often supported by relevant certifications. Familiarity with audit management software, document control systems, and regulatory databases is typically required. Outstanding attention to detail, analytical thinking, and effective communication are critical soft skills for evaluating compliance and reporting findings. These skills ensure thorough, accurate audits that help organizations meet regulatory requirements and maintain product safety and quality.

What is the difference between Contract Medical Device Auditor vs Contract Quality Assurance Specialist?

AspectContract Medical Device AuditorContract Quality Assurance Specialist
CertificationsISO 13485 Lead Auditor, FDA regulationsISO 13485, FDA compliance, GMP training
Work EnvironmentAuditing facilities, reviewing documentationDeveloping, implementing quality processes
Employer & IndustryMedical device companies, consulting firmsMedical device manufacturers, biotech firms
Search & Comparison IntentUnderstanding auditing roles, compliance checksQuality management, process improvement

While both roles focus on ensuring medical device quality, Contract Medical Device Auditors primarily conduct audits to verify compliance with standards like ISO 13485 and FDA regulations. Contract Quality Assurance Specialists develop and maintain quality systems, ensuring ongoing compliance and process improvements. The auditor role is more inspection-focused, whereas the QA specialist role involves proactive quality management.

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Contract Medical Device Auditor jobs near you
Infographic showing various Contract Medical Device Auditor job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $44,967 per year, or $21.6 per hour.

Contract Opportunity - Medical Device Auditors

SGS

Remote

Contractor

Posted 8 days ago

Job description

Company Description
SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 96,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
Job Description
This is a Contract role - must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.
We are looking for Contract Medical Device Auditors with:
  • Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
  • Non-active, non-implantable ophthalmologic devices (2+ years)
  • General non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (2+ years)
  • Sterilization experts (primarily EtO, Irradiation and Moist Heat, as well as other sterilization technologies)
  • ISO 9001 qualification

As a Contract Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and MDR. You will be responsible for making relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification.
  • Perform audits for clients' medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.
  • Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
  • Participate actively in witness audits by SGS or accreditation bodies.
  • Maintain all audit credentials.
  • Adheres to internal standards, policies, and procedures

Qualifications
Education and Experience
  • Bachelor's degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.) AND
  • Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
  • Preferred: Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR
  • Preferred: experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems
  • Preferred: GMP (pharmaceutical, cosmetics, dietary supplements, etc.) quality / regulatory experience

Knowledge/ Skills/ Abilities
  • Non-active cardiovascular, vascular, and neurovascular implants (MDN1101)
  • Non-active, non-implantable ophthalmologic devices (MDN1206)
  • General non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (MDN1214)
  • Sterilization technologies (primarily EtO, Irradiation and Moist Heat, other technologies are also considered)
  • ISO 9001 qualification
  • Strong background and knowledge of technical applications of the standards
  • Language Skills: Highest advanced level of English, additionally Spanish preferred
  • Excellent communication and interpersonal, verbal, written and presentation skills
  • Proactive attitude and excellent organizational skills
  • Effectively reacts in stressful situations and makes clear, well-founded decisions regarding conformity during the audit
  • Ability to multitask and manage multiple projects while delivering results on time
  • Act with integrity, tact and character
  • Computer Skills
  • MS Office Suite (Word, Excel, PowerPoint) - Intermediate user proficiency

Travel
  • Travels up to 80% of the time (automobile & airplane).
  • Weekend travel may be necessary to meet scheduling requirements.

Additional Information
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
All your information will be kept confidential according to EEO guidelines.

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