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Mdsap Auditor Jobs (NOW HIRING)

Apple

Senior Lead Auditor (Medical Devices)

Cupertino, CA · On-site

$99K - $122K/yr

ISO 13485, MDSAP requirements, China GMP, EU MDR, China GMP, etc...) Excellent written and verbal ... auditor certification or internal auditor certification Attention to detail, well organized and ...

Propeller Health

Quality Auditor

San Diego, CA · On-site

... MDSAP) and European Union Regulations. The role will interact with stakeholders including suppliers, external auditors and internal ResMed departmental managers. Also, the role will be responsible ...

ResMed

Quality Auditor

San Diego, CA · On-site

... MDSAP) and European Union Regulations. The role will interact with stakeholders including suppliers, external auditors and internal ResMed departmental managers. Also, the role will be responsible ...

MatrixCare

Quality Auditor

San Diego, CA · On-site

... MDSAP) and European Union Regulations. The role will interact with stakeholders including suppliers, external auditors and internal ResMed departmental managers. Also, the role will be responsible ...

ResMed, Inc.

Quality Auditor

San Diego, CA · On-site

... MDSAP) and European Union Regulations. The role will interact with stakeholders including suppliers, external auditors and internal ResMed departmental managers. Also, the role will be responsible ...

Getinge

Internal Auditor Corporate Quality

Nashua, NH · Remote

You just found it. Job Overview The Corporate Quality Internal Auditor will perform Global Internal ... Evidence of training to QSmR, ISO 13485:2016, EU MDR, MDSAP and ISO 9001:2015 * Valid passport and ...

Getinge

Internal Auditor Corporate Quality

Nashua, NH · On-site

You just found it. Job Overview The Corporate Quality Internal Auditor will perform Global Internal ... Evidence of training to QSmR, ISO 13485:2016, EU MDR, MDSAP and ISO 9001:2015 * Valid passport and ...

BSI Prof Serv EHS West

Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation) * Initially observe how audits are conducted but then grow to ...

BSI Group

Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation) * Initially observe how audits are conducted but then grow to ...

Medline

Manager Quality Assurance, Audit

Lead and Mentor auditors on the internal audit team and conduct trainings for the team as required ... 13485, ISO 14971, MDSAP, and MDR). * Broad technical knowledge of relevant standards and ...

Medline

Sr Auditor QA

$92K - $138K/yr

... MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse ... Work Experience - At least 4 years of experience auditing FDA regulated medical Device or ...

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Mdsap Auditor information

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$30.5K

$72.6K

$117.5K

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 Lead Auditor (Medical Devices)

Cupertino, CA • On-site

Apple
Computer and Electronic Product Manufacturing • 10K+ employees
Learn more about Appleexternal

$99K - $122K/yr

Full-time

Re-posted 29 days ago

Apple rating

8.1

Company rating: 8.1 out of 10

Based on 686 frontline employees who took The Breakroom Quiz

Job description

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other's ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It's the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you'll do more than join something - you'll add something.
Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices -strengthening our commitment to leave the world better than we found it.
Description
The Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.
The Senior Lead Auditor will lead and maintain a risk based internal & supplier audit program to ensure ongoing regulatory compliance and encourage continuous improvement.
Minimum Qualifications
Bachelor's Degree or equivalent experience
5+ years of experience in Quality Management Systems supporting Medical Devices
Extensive experience in performing audits to regulatory requirements
Knowledge of medical device regulatory requirements (e.g. ISO 13485, MDSAP requirements, China GMP, EU MDR, China GMP, etc...)
Excellent written and verbal communication skills
Excellent interpersonal skills working across multiple divisions
Some travel is required
Ability to be onsite; this role is a hybrid, in-person position
Preferred Qualifications
Experience with software medical device products
Lead auditor certification or internal auditor certification
Attention to detail, well organized and time efficient
Can multi-task and work independently

What Apple employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

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About Apple

Sourced by ZipRecruiter

Imagine what you could do here! At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no telling what you could accomplish. Dynamic, intelligent people and inspiring, innovative technologies are the norm here. The people who work here have reinvented entire industries with all Apple Hardware products. The same real passion for innovation that goes into our products also applies to our practices strengthening our dedication to leave the world better than we found it.

Industry

Computer and electronic product manufacturing

Company size

10,000+ Employees

Headquarters location

Cupertino, CA, US

Year founded

1976

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