What qualifications are needed for this role?

A degree in engineering, quality management, or a related field is typically required. Relevant certifications such as CQA (Certified Quality Auditor) are also beneficial.

What are the key skills for a Medical Device Quality Engineer?

Key skills include attention to detail, strong problem-solving abilities, knowledge of regulatory standards, and excellent communication and collaboration skills.

How does this role differ from a Regulatory Affairs Specialist?

While both roles focus on compliance, a Medical Device Quality Engineer primarily ensures the quality and safety of products during development and manufacturing, whereas a Regulatory Affairs Specialist focuses on obtaining and maintaining regulatory approvals.

What is the typical salary range for this role?

Salary ranges can vary based on experience, location, and company size. For more detailed information, please refer to the salary section on this page.

Medical Device Quality Engineer Jobs

Engineers who ensure the safety, reliability, and compliance of medical devices. A critical role in the MedTech industry, bridging technical expertise with regulatory standards.

Open roles

Hiring companies

View 2 live roles → Get an alert

Medical Device Quality Engineers play a vital role in ensuring that medical devices meet the highest standards of safety, reliability, and regulatory compliance. These professionals work across various stages of the product lifecycle, from design and development to manufacturing and post-market surveillance. They collaborate with cross-functional teams, including engineers, regulatory affairs specialists, and clinical researchers, to identify and mitigate potential risks and ensure that products comply with international standards and regulations.

What the role does

Inside the role of a Medical Device Quality Engineer

A typical week is split between project management, quality assurance activities, and regulatory compliance tasks.

01

Conduct quality audits and inspections.
02

Review and update quality management systems.
03

Collaborate with cross-functional teams on risk assessments.
04

Prepare and submit regulatory documentation.
05

Monitor and report on non-conformances and corrective actions.
06

Stay updated on industry standards and regulations.

Skills & tools

What hiring managers ask for

% of 1 listings posted in the last 12 months that mention each skill, extracted from job descriptions.

ISO 13485

100%

CAPA

100%

Quality Engineering

100%

Supplier Management

100%

Design for Manufacture

100%

Lead Auditor

100%

Career ladder

From Junior to Principal

A typical UK progression for medical device quality engineers. Years are guidance — strong people move faster, and many senior folks sidestep into research, product or management.

Level 1

Junior Medical Device Quality Engineer

0–2 yrs

Assists in quality assurance activities and learns the regulatory landscape under supervision.
Level 2

Medical Device Quality Engineer

2–5 yrs

Takes ownership of specific quality processes and leads small projects.
Level 3

Senior Medical Device Quality Engineer

5–10 yrs

Manages multiple quality processes and mentors junior engineers.
Level 4

Principal Medical Device Quality Engineer

10+ yrs

Leads the quality function, drives strategic initiatives, and advises senior management.

Pathway

How to become a Medical Device Quality Engineer

There's no single route, but most people follow some version of these steps.

1

Entry-Level Quality Assurance

Start with basic quality assurance tasks and learn the fundamentals of medical device regulations.
2

Specialised Quality Processes

Gain expertise in specific quality processes and begin leading small projects.
3

Project Management

Take on more significant responsibilities, managing multiple quality processes and leading teams.
4

Strategic Leadership

Drive strategic quality initiatives, advise senior management, and mentor junior engineers.
5

Industry Expert

Become a recognised expert in medical device quality, influencing industry standards and best practices.

Live jobs

2 live roles

Supplier Quality Engineer - Medical Devices - Oxford

The Supplier Quality Engineer will manage and develop the supplier base for a rapidly growing medical devices company, ensuring compliance with ISO 13485 standards. Responsibilities include evaluating suppliers, managing CAPAs, and applying quality expertise to design-for-manufacture considerations.

Newton Colmore Oxford, Oxfordshire, United Kingdom

On-site Permanent

Quality Engineer, Medical Devices

Quality Engineer, Medical DevicesBasic Salary £40,000 to £50,000HealthcarePensionThe Role - Quality Engineer, Medical DevicesFollowing expansion, they seek to recruit a Quality Engineer responsible for all aspects of quality management including:Drafting processes, procedures and documentationPerforming internal auditsManaging and resolving complaintsYour Background...

TRS Consulting Bolton, Manchester, M26 1HG, United Kingdom £40,000 – £50,000 pa

Hiring locations

Where this role is hiring

The locations with the most live listings for this role today.

FAQs

Common questions

A degree in engineering, quality management, or a related field is typically required. Relevant certifications such as CQA (Certified Quality Auditor) are also beneficial.
Key skills include attention to detail, strong problem-solving abilities, knowledge of regulatory standards, and excellent communication and collaboration skills.
While both roles focus on compliance, a Medical Device Quality Engineer primarily ensures the quality and safety of products during development and manufacturing, whereas a Regulatory Affairs Specialist focuses on obtaining and maintaining regulatory approvals.
Salary ranges can vary based on experience, location, and company size. For more detailed information, please refer to the salary section on this page.

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Medical Device Quality Engineer Jobs

Inside the role of a Medical Device Quality Engineer

What hiring managers ask for

From Junior to Principal

Junior Medical Device Quality Engineer