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Mdsap Auditor Jobs (NOW HIRING)

BSI Group

Medical Device QMS Auditor

Atlanta, GA · On-site

$98K - $123K/yr

QMS Auditor Location: Must be located in the Atlanta, Georgia area Do you believe the world ... Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes. * Prepare assessment ...

BSI Group

Medical Device QMS Auditor

Raleigh, NC · On-site

$98K - $123K/yr

QMS Auditor Location: Must be located in the Atlanta, Georgia area Do you believe the world ... Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes. * Prepare assessment ...

Medline

Auditor QA

$79K - $119K/yr

... MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse ... At least 2 years of experience auditing FDA regulated medical device or pharmaceuticals ...

atrion

Quality Engineering Manager

Davie, FL · On-site

... auditing, and risk management activities with respect to global regulatory requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and TGA). General Duties and Responsibilities : * Ensure the ongoing ...

Omnex Inc

Omnex Consultant ISO 13485

Ann Arbor, MI · On-site

MDSAP * Risk Management (ISO 14971 & ISO 24971) * SaMD (Software as a Medical Device), & SiMD ... Cybersecurity Guidance * Core Tools (APQP, FMEA, MSA, SPC, & PPAP) Auditor background and ...

Filtration Group

Quality Assurance Manager

Louisville, CO · On-site

$120K - $140K/yr

Internal Auditing, Customer Feedback, Change Orders/Document Control, Non-conforming Material ... The QA Manager will schedule and conduct audits of the QMS to the ISO 9001, ISO 13485, MDSAP ...

DENTALEZ

Quality Engineer

Bay Minette, AL · On-site

$72K - $93K/yr

Working knowledge of ISO 13485, MDSAP, FDA 21 CFR 820, and MDD/MDR. * Internal Auditor experience required; ASQ CQE or Six Sigma certification preferred. * Strong analytical, metrology, and problem ...

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Mdsap Auditor information

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$30.5K

$72.6K

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How much do mdsap auditor jobs pay per year?

As of Sep 15, 2026, the average yearly pay for mdsap auditor in the United States is $72,633.00, according to ZipRecruiter salary data. Most workers in this role earn between $47,000.00 and $98,500.00 per year, depending on experience, location, and employer.

What is an MDSAP auditor?

MDSAP Auditors are professionals authorized to assess medical device manufacturers for compliance with the Medical Device Single Audit Program (MDSAP) requirements. They evaluate whether companies meet the regulatory standards of participating countries, such as the US, Canada, Australia, Brazil, and Japan, through a single comprehensive audit. Their role involves reviewing quality management systems, production processes, and documentation to ensure patient safety and regulatory adherence.

What are the key skills and qualifications needed to thrive as an MDSAP auditor?

To thrive as an MDSAP Auditor, you need a solid background in quality management systems, regulatory compliance, and auditing principles, typically backed by a degree in science or engineering and relevant auditor certifications. Familiarity with ISO 13485, FDA regulations, Health Canada, and other global regulatory frameworks, as well as audit management software, is essential. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills ensure accurate, comprehensive audits that help medical device organizations maintain compliance and patient safety on a global scale.

What are some common challenges faced by MDSAP auditors during multi-country audits?

MDSAP Auditors often encounter challenges such as navigating differing regulatory requirements across participating countries, coordinating communication among multinational client teams, and managing complex documentation in various languages. Additionally, balancing thoroughness with audit time constraints can be demanding, as auditors must ensure full compliance with standards while respecting client schedules. Collaboration with cross-functional teams and adaptability to evolving regulations are key to successfully overcoming these challenges.

What is the difference between Mdsap Auditor vs ISO 13485 Auditor?

AspectMdsap AuditorISO 13485 Auditor
CertificationsRequires MDSAP-specific training and certificationRequires ISO 13485 certification
Work EnvironmentAudits medical device manufacturers for MDSAP complianceAudits medical device quality management systems for ISO 13485
Industry UsagePrimarily in countries participating in MDSAPGlobal, across industries requiring ISO 13485

The Mdsap Auditor and ISO 13485 Auditor roles share similarities in auditing medical device quality systems but differ mainly in scope and certification. Mdsap Auditors focus on compliance with MDSAP requirements, often in specific countries, while ISO 13485 Auditors assess adherence to international quality standards applicable worldwide. Both roles require specialized training and are vital in ensuring medical device safety and quality.

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Mdsap Auditor jobs near you
Infographic showing various Mdsap Auditor job openings in the United States as of September 2026, with employment types broken down into 91% Full Time, 6% Part Time, 2% Contract, and 1% Nights. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $72,633 per year, or $34.9 per hour.

Senior Manager-Global Quality Systems

Trumbull, CT • On-site

Cooper Companies
See more jobs at Cooper Companiesexternal

Full-time

Posted 25 days ago

Job description

Scope: 

The Senior Manager, Global Quality Systems provides leadership and oversight for key elements of CooperSurgical's Global Quality Management System (QMS), including Management Review, Quality System Metrics and Reporting, Regulatory Intelligence, Quality System Impact Assessments, and Quality System integration activities associated with acquisitions and strategic business initiatives. Partners closely with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, IT, and other functional leaders to ensure QMS remains compliant, effective, scalable, and aligned with evolving regulatory requirements and business objectives.  Serves as a key partner to the Director, Global Quality Systems, helping drive quality system performance, governance, inspection readiness, and continuous improvement across the global organization.

Qualifications

Knowledge, Skills and Abilities:

Required

  • Strong working knowledge of MasterControl, Veeva, Trackwise, or similar eQMS platforms. 
  • Solid understanding of 21 CFR 820, ISO 13485, EU MDR, MDSAP. 
  • Demonstrated ability to manage and develop teams. 
  • Ability to balance operational priorities with compliance requirements. 
  • Strong organizational, analytical, and communication skills. 
  • Ability to collaborate across global, crossfunctional groups.

Preferred

  • Experience participating in or supporting large-scale enterprise software implementations, including data migration and data mapping activities.
  • Advanced proficiency in Excel for data analysis and reporting.
  • Professional certification such as Certified Quality Auditor (CQA) or similar.

Work Environment:

  • Standard office environment with regular use of computer systems and virtual collaboration tools. 

Experience:

Required

  • 8+ years of experience in quality management systems, within a regulated med tech industry.
  • 7+ years of people leadership and team development.
  • Experience managing quality systems with ISO 13485 and FDA 21 CFR Part 820, MDSAP, and EU MDR requirements.

Preferred

  • Exposure to other adjacent quality system compliance requirements such as 21 CFR Part 210/211.
  • Prior involvement in supporting external and internal audits.
  • Experience with electronic Quality Management Systems (eQMS) and/or implementation of eQMS, such as Veeva, Trackwise, MasterControl.

Education:

Required

  • Bachelor's degree in a relevant field such as Engineering, Life Sciences, Quality, or a related discipline.

Preferred

  • Professional ASQ certification (CQPA, CQA, CMQ/OE, etc.)
  • Project Management Professional certification (PMP)

Qualifications

Knowledge, Skills and Abilities:

Required

  • Strong working knowledge of MasterControl, Veeva, Trackwise, or similar eQMS platforms. 
  • Solid understanding of 21 CFR 820, ISO 13485, EU MDR, MDSAP. 
  • Demonstrated ability to manage and develop teams. 
  • Ability to balance operational priorities with compliance requirements. 
  • Strong organizational, analytical, and communication skills. 
  • Ability to collaborate across global, crossfunctional groups.

Preferred

  • Experience participating in or supporting large-scale enterprise software implementations, including data migration and data mapping activities.
  • Advanced proficiency in Excel for data analysis and reporting.
  • Professional certification such as Certified Quality Auditor (CQA) or similar.

Work Environment:

  • Standard office environment with regular use of computer systems and virtual collaboration tools. 

Experience:

Required

  • 8+ years of experience in quality management systems, within a regulated med tech industry.
  • 7+ years of people leadership and team development.
  • Experience managing quality systems with ISO 13485 and FDA 21 CFR Part 820, MDSAP, and EU MDR requirements.

Preferred

  • Exposure to other adjacent quality system compliance requirements such as 21 CFR Part 210/211.
  • Prior involvement in supporting external and internal audits.
  • Experience with electronic Quality Management Systems (eQMS) and/or implementation of eQMS, such as Veeva, Trackwise, MasterControl.

Education:

Required

  • Bachelor's degree in a relevant field such as Engineering, Life Sciences, Quality, or a related discipline.

Preferred

  • Professional ASQ certification (CQPA, CQA, CMQ/OE, etc.)
  • Project Management Professional certification (PMP)

Essential Functions & Accountabilities:

  • Support the governance, effectiveness, and continuous improvement of the global QMS.
  • Drive harmonization, compliance, and operational excellence across global quality system processes. 
  • Partner with process owners and cross-functional stakeholders to identify and mitigate quality system risks while ensuring inspection readiness.
  • Lead the global Management Review program, including planning, reporting, action tracking, and continuous improvement. 
  • Develop and maintain quality system KPIs, dashboards, and performance reporting to provide visibility into QMS effectiveness, compliance status, and emerging risks. 
  • Prepare executive-level reporting on QMS health, quality objectives, risks, and improvement opportunities.
  • Monitor process effectiveness and drive improvements that enhance compliance, efficiency, and user experience.
  • Monitor evolving global regulations, standards, guidance documents, and industry best practices impacting the Quality Management System. 
  • Lead quality system impact assessments and gap analyses to determine the effect of regulatory and standards changes on existing QMS processes.
  • Develop and track implementation plans to ensure timely incorporation of regulatory and standards requirements into the QMS.
  • Partner with Regulatory Affairs and Quality leadership to evaluate new or revised regulatory requirements.
  • Lead Quality Systems due diligence, integration planning, and QMS harmonization activities associated with acquisitions and strategic business initiatives. 
  • Assess quality system maturity, identify compliance gaps, and implement integration plans that align acquired entities with CooperSurgical processes. 
  • Support implementation and optimization of electronic Quality Management Systems (eQMS) and related quality system enhancement initiatives.
  • Support regulatory inspections, audits, and remediation activities as required.
  • Lead, coach, and develop a team responsible for Quality Systems governance, reporting, compliance monitoring, and improvement initiatives.
  • Establish performance expectations, prioritize resources, and foster a culture of quality, accountability, and continuous improvement.

Travel: 

This position may require 20% domestic or international travel. 

Job Summary:

The Senior Manager, Global Quality Systems is responsible for the leadership, oversight, and continuous improvement of key components of CooperSurgical's Global Quality Management System. This role ensures ongoing compliance with applicable global regulations and standards, including FDA QMSR, ISO 13485, MDSAP, EU MDR, and other relevant requirements.  Leads activities related to Management Review, Quality System metrics and reporting, regulatory intelligence, standards management, quality system impact assessments, and merger and acquisition integration efforts. Through effective governance, analytics, and cross-functional collaboration, this role provides visibility into QMS health, identifies compliance risks and opportunities, and ensures regulatory and standards changes are effectively assessed and incorporated into the Quality Management System.

Essential Functions & Accountabilities:

  • Support the governance, effectiveness, and continuous improvement of the global QMS.
  • Drive harmonization, compliance, and operational excellence across global quality system processes. 
  • Partner with process owners and cross-functional stakeholders to identify and mitigate quality system risks while ensuring inspection readiness.
  • Lead the global Management Review program, including planning, reporting, action tracking, and continuous improvement. 
  • Develop and maintain quality system KPIs, dashboards, and performance reporting to provide visibility into QMS effectiveness, compliance status, and emerging risks. 
  • Prepare executive-level reporting on QMS health, quality objectives, risks, and improvement opportunities.
  • Monitor process effectiveness and drive improvements that enhance compliance, efficiency, and user experience.
  • Monitor evolving global regulations, standards, guidance documents, and industry best practices impacting the Quality Management System. 
  • Lead quality system impact assessments and gap analyses to determine the effect of regulatory and standards changes on existing QMS processes.
  • Develop and track implementation plans to ensure timely incorporation of regulatory and standards requirements into the QMS.
  • Partner with Regulatory Affairs and Quality leadership to evaluate new or revised regulatory requirements.
  • Lead Quality Systems due diligence, integration planning, and QMS harmonization activities associated with acquisitions and strategic business initiatives. 
  • Assess quality system maturity, identify compliance gaps, and implement integration plans that align acquired entities with CooperSurgical processes. 
  • Support implementation and optimization of electronic Quality Management Systems (eQMS) and related quality system enhancement initiatives.
  • Support regulatory inspections, audits, and remediation activities as required.
  • Lead, coach, and develop a team responsible for Quality Systems governance, reporting, compliance monitoring, and improvement initiatives.

  • Establish performance expectations, prioritize resources, and foster a culture of quality, accountability, and continuous improvement.

    Travel: This position may require 20% domestic or international travel. 

Apply