Quality Systems Engineer

Austin Fraser; Chelmsford; On-site; GBP 40,000 - 70,000; Full time

Job summary

An exciting opportunity awaits a Quality Systems Engineer at a fast-growing medical device company that has recently expanded through acquisition. This role is pivotal in integrating a new company's Quality Management System (QMS) into the existing framework, ensuring compliance with global standards such as ISO 13485:2016 and MDR. You will lead projects, collaborate with diverse teams, and focus on continuous improvement initiatives. If you thrive in a regulated environment and enjoy making a tangible impact in the medtech sector, this position offers a chance to take ownership and drive quality excellence in a dynamic setting.

Qualifications

• Experience in a regulated/medical device environment is essential.
• Strong knowledge of ISO standards and hands-on QMS integration experience.

Responsibilities

• Lead QMS integration and alignment projects with cross-functional teams.
• Manage SOPs, documentation, and drive continuous improvement initiatives.

Skills

QMS integration

ISO 13485

ISO 14971

MDR compliance

21 CFR Part 820

auditing skills

supplier management

root cause analysis

attention to detail

communication skills

Tools

eQMS platform

Job description

I'm working on a fantastic Quality Systems Engineer opportunity with a fast-growing medical device business that's recently completed an acquisition.

This role will be key in integrating the newly acquired company's QMS into the existing quality framework. Once integration is complete, the focus will shift to maintaining and continuously improving the system, with a strong emphasis on compliance to global standards like ISO 13485:2016, MDR 2017/745, UK MDR 2002, and 21 CFR 820.

What you'll be doing:

1. Leading QMS integration and alignment projects
2. Collaborating with cross-functional teams to identify and close gaps
3. Supporting transition to a new eQMS platform
4. Managing SOPs, forms, and documentation for ongoing compliance
5. Handling CAPAs, NCRs, internal audits, supplier controls & QMS improvements
6. Driving continuous improvement and lean quality initiatives
7. Preparing for and supporting supplier and external audits

What we're looking for:

1. Experience in a regulated/medical device environment
2. Strong knowledge of ISO 13485, ISO 14971, MDR, 21 CFR Part 820
3. Hands-on QMS integration/project experience
4. Solid auditing, supplier management, and root cause analysis skills
5. Excellent attention to detail, communication, and multitasking skills

This is a great opportunity for someone who enjoys project ownership, cross-functional collaboration, and making a real impact in a scaling medtech business. If you'd like to hear more or know someone who'd be a good fit, feel free to drop me a message or apply to this advert with your updated CV.