Senior Engineer Design Quality

ZipRecruiter; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global leader in MedTech is seeking a Senior Design Quality Engineer to ensure device safety and regulatory compliance. You will drive quality processes and collaborate on product development. Ideal candidates have over 7 years of experience in Quality or R&D, knowledge of ISO standards, and a Bachelor's degree in Engineering. This position offers competitive compensation and health benefits, alongside opportunities for professional growth.

Benefits

Comprehensive health coverage

Retirement & financial support

PTO packages and paid leave options

Flexible work options

Competitive compensation and bonus potential

Qualifications

• 7+ years of experience in Quality or R&D.
• Familiar with ISO 13485, ISO 14971, and 21 CFR 820.
• In depth experience with FDA and EU MDR regulations.

Responsibilities

• Drive quality processes for product development.
• Ensure regulatory compliance and device safety.
• Participate in design and test readiness reviews.

Skills

Quality processes

Regulatory compliance

Statistical analysis

Risk management

Education

Bachelor’s in Engineering or related field

ASQ CQE certification

Job description

Job Description

Are you a seasoned Quality Engineer ready to lead the charge in design excellence within MedTech? Looking for a role where your expertise shapes the future of healthcare? If so, our client is looking for a Senior Design Quality Engineer to help develop the next of innovative medical devices and you could be the perfect fit.

Who’s it for and what’s in it for you?

Our client are a global leader in innovative infusion therapy and critical care technologies, helping to make healthcare safer for patients and providers. They're growing fast, investing in new technologies, and building a culture where collaboration, quality, and purpose matter.

What’s in it for you?

Aside from joining a tight-knit, highly skilled team working on tech that saves lives, you’ll get:

• Comprehensive health coverage
• Retirement & financial support
• PTO packages and paid leave options
• Flexible work options
• Competitive compensation and bonus potential

What will your day to day look like?

You’ll be the go-to quality expert on when it comes to product development. This role is all about driving quality processes, ensuring regulatory compliance, and making sure the devices are safe, reliable, and effective.

You’ll be doing things like:

• Working on product development projects
• Driving risk management processes
• Supporting design verification and validation activities
• Making sure everything complies with global standards
• Getting involved in design and test readiness reviews
• Participating in design transfers
• Supporting audits and regulatory inquiries

You’ll also get the chance to work on special projects and grow your expertise in a regulated environment.

This role will suit you if you...

• Have 7+ years of experience in Quality or R&D
• Are familiar with ISO 13485, ISO 14971, and 21 CFR 820
• Have in depth experience with and knowledge of FDA and EU MDR regulations
• Are confident in statistical analysis and sample size calculations
• Hold a Bachelor’s in Engineering or a related field
• Have (or can obtain) ASQ CQE certification

Think this could be your next role?

Then we’d love to hear from you! If you’re interested in applying or would like to see the full job description for this role, please get in touch with Tommy on [e-mail]

The fine print

Reference number: 20035

Temporary or Permanent: Permanent

FMC contact for this role: Tommy Currie