Quality Control/Assurance Engineer Medical Devices

Job description

Job Summary           

Medasil Surgical Limited is seeking a Quality Control/Assurance Engineer to support Medical Device manufacturing operations through inspection, compliance, and quality activities. The role is hands-on and primarily focused on production. The successful candidate shall contribute to maintaining and improving various aspects of the QMS system. The role reports to the QA/RA Director.

Company Description

Medasil Surgical Limited is a leading UK-based medical device company specialising in the design, manufacture, and supply of single-use surgical products. With a strong reputation for quality, and customer focus, we are committed to delivering safe and effective solutions to healthcare professionals worldwide.

Duties and Responsibilities

•       Goods-in material inspection and product release

•       In-process and final quality control inspections

•       Review and sign off batch documentation

•       Equipment inspection, maintenance logs and calibration activities

•       Environmental and bioburden monitoring

•       Cross functional departmental training for compliance

•       Record and report rejects and rework.

•       Support Change control, on-conformance, Supplier approvals and Customer requests.

•       Assist in maintaining accurate QMS records and documents.

•       Ensure compliance with ISO 13485 EU-MDR and UK-MDR regulations and cGMP.

•       Support continuous improvement initiatives

•       Support validation and FMEA activities.

•       Maintain safe and clean working area

•       Occasional heavy lifting

•       Requires walking between various areas, standing, sitting bending and reaching

Essential Requirements:

•       Experience in medical device industry or similar regulated environment

•       Knowledge of ISO 13485, EU-MDR and UK-MDR regulations and cGMP.

•       Experience working with Quality Management Systems or similar

•       Proficient in Microsoft Office applications

•       Strong attention to detail

•       Excellent written and verbal communication skills

•       Minimum of 4 year's previous experience in Quality control/Assurance

•       Experience in metrology and understanding Technical drawings.

•       Degree in Engineering, Quality Management, or a related field is preferred

Desirable:

•       Knowledge of ISO13485, EU-MDR 2017/745 and MDD 93/42/EEC

•       LEAN manufacturing understanding

•       Cleanroom experience

Skills

•       Strong organisational and time management skills

•       Self-motivated and adaptable

•       Team player with good interpersonal skills

•       Good manual dexterity

•       Ability to work under tight deadlines and change in priorities

•       Internal auditor (preferable)

Medasil Surgical Limited is an equal‑opportunity employer. We welcome applications from all qualified individuals regardless of background and identity.

If you're interested in contributing to high-quality medical device manufacturing in a regulated environment, apply today.

This is a full‑time, permanent on‑site role based in Leeds, UK. Please only apply if you are able to commute to our Leeds location or are willing to relocate.

Extra information

Status

Open

Education Level

Secondary School

Location

Leeds

Type of Contract

Full-time jobs

Published at

03-04-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English