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Medical Device Quality Management System Auditor Jobs

We are seeking an internal Quality Management System Auditor at our Tucson, AZ facility. The ... Hired applicants may be eligible for benefits, including but not limited to, medical, dental ...

Strong knowledge of risk management principles and medical device regulatory reporting requirements ... Excellent ability to analyze complex quality systems and processes and identify compliance gaps.

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 ...

... medical device industry,including experience as a Quality Systems Auditor, and competent working knowledge of nationallyrecognized Quality Management System auditing standards and procedures. * In ...

... maintain key Quality Management System (QMS) processes within a regulated medical device ... ASQ Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), ISO 13485 Lead Auditor, or ...

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Medical Device Quality Management System Auditor information

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$12

$38

$143

How much do medical device quality management system auditor jobs pay per hour?

As of Jun 27, 2026, the average hourly pay for medical device quality management system auditor in the United States is $38.60, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $32.69 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Medical Device Quality Management System Auditor, and why are they important?

To thrive as a Medical Device Quality Management System Auditor, you need in-depth knowledge of regulatory standards (such as ISO 13485), risk management, and quality assurance, often supported by a relevant science or engineering degree and auditor certification. Proficiency in audit management tools, document control systems, and familiarity with regulatory databases is typically required. Strong analytical thinking, attention to detail, and effective communication skills are essential for evaluating compliance and interacting with diverse stakeholders. These skills are crucial for ensuring product safety, regulatory compliance, and continuous improvement within the medical device industry.

What is the difference between Medical Device Quality Management System Auditor vs Medical Device Quality Control Inspector?

AspectMedical Device Quality Management System AuditorMedical Device Quality Control Inspector
Primary RoleAudits and assesses the QMS for compliance with standards like ISO 13485Inspects finished products for defects and quality issues
CertificationsISO 13485 Lead Auditor, CQEQuality Control certifications, such as CQI
Work EnvironmentAuditing facilities, documentation review, on-site assessmentsManufacturing lines, inspection stations
FocusProcess compliance, documentation, and system effectivenessProduct quality, defect detection

The Medical Device Quality Management System Auditor primarily evaluates the company's quality processes and compliance, ensuring adherence to standards. In contrast, the Medical Device Quality Control Inspector focuses on inspecting products for defects. Both roles are essential in the medical device industry but serve different purposes within quality assurance.

What are some common challenges faced by Medical Device Quality Management System Auditors when assessing compliance across different organizations?

Medical Device Quality Management System Auditors often encounter challenges such as varying interpretations of regulatory requirements, differences in documentation practices, and resistance to change from staff. Auditors must quickly adapt to diverse quality management systems and manufacturing processes while ensuring that all aspects meet international standards like ISO 13485 and FDA regulations. Building rapport with teams, asking the right questions, and staying up-to-date with evolving guidelines are essential to overcome these challenges and conduct effective, unbiased audits.

What is a Medical Device Quality Management System Auditor?

A Medical Device Quality Management System Auditor is a professional responsible for evaluating and verifying that a medical device manufacturer's quality management system complies with applicable regulations and standards, such as ISO 13485. They conduct audits to ensure processes and documentation meet quality and safety requirements, identifying areas for improvement and ensuring compliance to minimize risks. Their work is essential in helping organizations maintain certifications, ensure product safety, and meet regulatory expectations in the medical device industry.
Infographic showing various Medical Device Quality Management System Auditor job openings in the United States as of June 2026, with employment types broken down into 73% Full Time, 3% Part Time, 19% Contract, and 5% Nights. Highlights an 95% In-person, and 5% Remote job distribution, with an average salary of $80,278 per year, or $38.6 per hour.
Quality Management System Auditor

Quality Management System Auditor

RTX

Tucson, AZ

$204K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 19 days ago


RTX rating

8.1

Company rating: 8.1 out of 10

Based on 84 frontline employees who took The Breakroom Quiz

34th of 60 rated aerospace companies


Job description

Date Posted:
2026-05-22
Country:
United States of America
Location:
US-AZ-TUCSON-801 1151 E Hermans Rd BLDG 801 (External Site)
Position Role Type:
Onsite
U.S. Citizen, U.S. Person, or Immigration Status Requirements:
The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance
Security Clearance Type:
DoD Clearance: Secret
Security Clearance Status:
Active and existing security clearance required after day 1
At RTX, the world largest aerospace and defense company, 185,000 great minds are united by purpose and inspired to make a difference solving the world's most complex problems. With our three market leading businesses, world-class operations and investments in research and development, we offer capabilities and opportunity no one else can. Together, we push the boundaries of known science and find new ways to connect and protect our world.
Raytheon brings the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. We deliver solutions that help our nation and allies defend freedom and deter aggression, creating a safer, more secure world. Join us and help shape the future of aerospace and defense.
The Raytheon Quality Management System (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing customer satisfaction.
We are seeking an internal Quality Management System Auditor at our Tucson, AZ facility. The successful candidate will primarily support various locations in Tucson and other Raytheon sites as needed. The role requires a strong understanding of AS9100, ISO 9001:2015, effective communication skills, and the ability to work independently.
This is an onsite role in Tucson, AZ.
What You Will Do:
  • Oversee, conduct, and plan internal QMS audits for compliance to the AS9100 series of standards in support of the Raytheon Quality Management System. The focus of this role will be the Tucson sites and will also include audits at other Raytheon locations.
  • Perform all formal responsibilities of a Lead Auditor such as audit team selection; audit planning; representing the audit team with Raytheon's site stakeholders; conducting opening and closing meetings and daily debriefs with stakeholders; completing an audit report; and issuing, reviewing, and approving formal corrective actions.
  • Serve as a liaison and interface to the Enterprise Audit Team during site audits.
  • Facilitate the Enterprise Audit schedules, logistics, and closure of corrective actions.
  • Serve as liaison and interface to Raytheon's Certification body (NQA) during site certification or recertification audits.
  • Facilitate NQA audit schedules, logistics, and closure of corrective actions.
  • Prepare the sites for the Enterprise and NQA Audits.
  • Perform other audits as deemed appropriate at the sites.
  • Facilitate corrective action responses with process owners, including advanced root cause analysis resources.
  • Ensure corrective actions are effectively implemented and closed as scheduled.
  • Travel up to 25%.

Qualification You Must Have:
  • Typically requires a University Degree and a minimum of eight (8) years prior relevant experience in the following areas (In lieu of a degree, the candidate must have twelve (12) years of prior relevant experience);
    • At least six (6) years of QMS auditing experience within the Aerospace Industry.
    • Working experience in auditing to the AS9100 standards.
    • American Society for Quality Certification/Certified Quality Auditor Certification (ASQ/CQA) Certification or equivalent.
  • The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance.

Qualifications We Prefer:
  • A University Degree
  • Industry Aerospace Auditor (AEA) Certification.
  • Lead Auditor Certification.
  • Experience working without direct supervision.
  • Experience leading teams.

What We Offer:
  • Whether you're just starting out on your career journey or are an experienced professional, we offer a total rewards package that goes above and beyond with compensation; healthcare, wellness, retirement, and work/life benefits; career development and recognition programs.
  • Some of the benefits we offer include parental (including paternal) leave, flexible work schedules, achievement awards, educational assistance, and child/adult backup care.

Learn More & Apply Now!
Onsite: Employees who are working in onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.
Clearance Information: Clearance Information: This position requires a security clearance. DCSA Consolidated Adjudication Services (DCSA CAS), an agency of the Department of Defense, handles and adjudicates the security clearance process. More information about Security Clearances can be found on the US Department of State government website here: https://www.state.gov/m/ds/clearances/c10978.htm
As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.
The salary range for this role is 107,500 USD - 204,500 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.
Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.
Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.
This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.
RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
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