Quality Systems Engineer

GxPeople Global; Chelmsford; On-site; GBP 35,000 - 55,000; Full time

Job summary

An exciting opportunity awaits a Quality Systems Engineer at a fast-growing medical device company. This role is pivotal in integrating a newly acquired company's Quality Management System (QMS) into the existing framework, ensuring compliance with global standards. You will collaborate with cross-functional teams to drive continuous improvement initiatives and manage documentation for ongoing compliance. If you thrive in a dynamic environment and are passionate about quality assurance, this role offers the chance to make a significant impact in a scaling medtech business.

Qualifications

• Experience in a regulated/medical device environment is essential.
• Strong knowledge of ISO standards and compliance regulations.

Responsibilities

• Lead QMS integration and alignment projects effectively.
• Collaborate with teams to identify and close quality gaps.
• Manage documentation for compliance and support audits.

Skills

Regulated/medical device experience

Knowledge of ISO 13485

Knowledge of ISO 14971

Knowledge of MDR

Knowledge of 21 CFR Part 820

Auditing skills

Supplier management skills

Root cause analysis skills

Attention to detail

Communication skills

Multitasking 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:

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

What we’re looking for:

• Experience in a regulated/medical device environment
• Strong knowledge of ISO 13485, ISO 14971, MDR, 21 CFR Part 820
• Solid auditing, supplier management, and root cause analysis skills
• 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.

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance, Engineering, and Manufacturing

Industries

Medical Equipment Manufacturing