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Iso 13485 Jobs (NOW HIRING)

BSI Group

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

BSI Prof Serv EHS West

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

Balda C Brewer

Program Manager (ISO 13485)

Ontario, CA · On-site

$90K - $130K/yr

This position is responsible for performing engineering and program management tasks to integrate new products from concept to manufacturing in a contract manufacturing environment. Activities ...

DivIHN Integration Inc

Quality Manager

Oneonta, NY · On-site

This facility is undergoing a Quality System Transformation from ISO 9001 to ISO 13485. Looking for minimum of 2 years Project Management experience with managing this type of transition. ETQ ...

CorDx

Senior Production Manager

Atlanta, GA · On-site

ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. Quality & Process Improvement: Work closely with Quality ...

Aurora Lifesciences

Senior Quality Engineer

Manassas, VA · On-site

$87K - $118K/yr

Leading and supporting internal audits against ISO 13485 and ensuring actions are driven through to completion. * Supporting customer, supplier and regulatory audits. * Leading quality improvement ...

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How much do iso 13485 jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for iso 13485 in the United States is $21.09, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $21.63 per hour, depending on experience, location, and employer.

What is an ISO 13485?

An ISO 13485 job typically involves roles in quality management, regulatory compliance, and manufacturing within the medical device industry. Professionals in these roles ensure that companies adhere to ISO 13485, the international standard for quality management systems in medical devices. Responsibilities may include managing audits, maintaining documentation, overseeing regulatory compliance, and improving quality processes. These jobs are crucial for ensuring product safety, consistency, and compliance with regulatory requirements.

What are the typical day-to-day responsibilities of someone working in an ISO 13485 quality assurance role?

Professionals in an ISO 13485 quality assurance role are typically responsible for developing, implementing, and maintaining quality management systems specific to medical devices. Their daily tasks include preparing documentation, conducting internal audits, ensuring compliance with regulatory standards, managing nonconformances, and coordinating corrective actions. They often collaborate closely with engineering, manufacturing, and regulatory affairs teams to address quality issues and facilitate continuous improvement. This position involves significant attention to detail and communication to uphold the organization’s quality objectives and regulatory commitments.

What are the key skills and qualifications needed to thrive in the ISO 13485 position, and why are they important?

To thrive in an ISO 13485 role, you need a strong understanding of quality management systems for medical devices, regulatory requirements, and risk management principles, often supported by a background in engineering, life sciences, or quality assurance. Familiarity with audit processes, CAPA (Corrective and Preventive Action) systems, and certifications like Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor are highly valued. Attention to detail, problem-solving abilities, and effective communication set outstanding candidates apart. These skills ensure compliance with stringent regulations and help maintain product quality and patient safety in the medical device industry.

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Infographic showing various Iso 13485 job openings in the United States as of September 2026, with employment types broken down into 92% Full Time, 2% Part Time, 4% Contract, and 2% Nights. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $43,861 per year, or $21.1 per hour.

Japan medical device QMS 13485 auditor (relocation)

On-site, Remote

BSI Group
See more jobs at BSI Groupexternal

Full-time

Re-posted 28 days ago

Job description

Great that you're thinking about a career with BSI!

ISO
18081,000
1901ISO90
ISO 13485 QMS

（MUST）


（）

＊

（）

＊

（）

（WANT）


/


＊ＢＳＩ

：（）

＊ISO13485


：9：00～17：30（60）


：14（）

：

：（1）（60）

Medical Device 13485 Auditor in Japan /relocate to Japan(homebased)

We are looking for the candidate who is active searching this relocation opportunity in Japan.

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 assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

In the first six months of being a Medical Device Auditor you'll:

  • 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 conduct them on an individual basis on site at medical device manufacturers across EMEA and remotely from your home office.

In a typical week after being fully trained you'll:

  • Conduct an audit on site or remotely

  • Write up your reports and liaise with the planning team to manage your audit schedule.

  • You'll also continue your development of MDR and be an advocate for the ISO 13485 EMEA Delivery Team.

To thrive in this career, you must:

  • Have 4 years or more being directly accountable for the design or test or manufacture of different medical devices.

  • Be degree educated with discipline relevant to Medical Devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar.

  • Have at least 2 years' experience working in an environment with a Quality Management System established.

  • Be able to speak and write fluently in the Japanese and English language.

  • Be resilient and able to meet audit delivery by travelling frequently across the EMEA region as required

We're enthusiastic to receive applications from those based in Japan/ relocate to Japan excited by this career opportunity.

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Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is an Equal Opportunity Employer and we are committed to diversity.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

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