Product Quality Associate - Medical Devices

MEDASIL SURGICAL LIMITED; Leeds; On-site; GBP 27,000 - 36,000; Full time

Job summary

Medasil Surgical Limited in Leeds is seeking a Product Quality Associate to join our Quality team. You will support manufacturing on a daily basis, contribute to quality activities, perform inspections, oversee cleanroom compliance, and ensure products meet customer, quality, safety and regulatory standards.

This role suits candidates with 1–2 years in quality control/assurance or extensive cleanroom manufacturing experience, with a good grasp of cGMP and ISO 9001/13485.

Qualifications

• 1–2 years' experience in a Quality Control, Quality Assurance or manufacturing role within medical devices, biotechnology or another highly regulated industry.
• OR substantial cleanroom manufacturing experience and a genuine interest in moving into Quality.
• An understanding of cGMP, cleanroom disciplines within regulated manufacturing environments.

Responsibilities

• Performing incoming goods inspections and product release activities
• Conducting in-process quality inspections and final product sign-off
• Supporting all manufacturing functions with packaging compliance
• Coordinating environmental and bioburden monitoring for external contract service provider testing
• Assisting with CAPA investigations and continuous improvement activities
• Maintaining equipment calibration records and inspection logs
• Supporting operator training and compliance procedures
• Reviewing manufacturing processes and identifying improvement opportunities
• Ensuring compliance with ISO standards and medical device regulations
• Supporting documentation updates and quality records management

Skills

Quality control

Quality assurance

Medical devices

Cleanroom

Regulations

Tools

Excel

Word

Job description

Product Quality Associate - Medical devices

Medasil Surgical Ltd

Leeds | Full Time | Permanent | On-site

Working Hours:

Monday: 8:00am–4:30pm

Tuesday–Thursday: 7:30am–4:30pm

Friday: 7:30am–2:00pm

The Opportunity

Medasil Surgical Limited are seeking a Product Quality Associate to join our Quality team. This role would suit candidates with 1 to 2 years’ experience in Quality Control, Quality Assurance, Medical Device Manufacturing, OR extensive experience within Cleanroom production environments who are looking to develop a career in Quality.

This is an excellent opportunity for a quality-focused professional with experience in regulated manufacturing and cleanroom environments to play a key role in maintaining product compliance, supporting production quality, and driving continuous improvement initiatives.

You’ll be joining a collaborative Quality team where your work will directly contribute to product safety, operational excellence, and regulatory compliance.

This role is full time onsite in Leeds so only suitable for candidates who are within a commutable distance or activelylooking to relocate to Leeds.

There is no visa sponsorship for this role so only apply if you have full right to work in UK status without limits.

The Company

Medasil Surgical Limited, established in 1974, is a renowned manufacturer of silicone tubing and surgical devices utilized in operating theatres. Based in Leeds, the company supplies high-quality medical devices to the NHS, private hospitals, and specialist clinics across the UK, as well as exporting globally.

The Role

The successful candidate will be supporting manufacturing on a daily basis, contributing to quality activities, conducting inspections, overseeing cleanroom compliance, and ensuring products meet customer, quality, safety and regulatory standards and requirements.

Key responsibilities include:

• Performing incoming goods inspections and product release activities
• Conducting in-process quality inspections and final product sign-off
• Supporting all manufacturing functions with packaging compliance
• Coordinating environmental and bioburden monitoring for external contract service provider testing
• Assisting with CAPA investigations and continuous improvement activities
• Maintaining equipment calibration records and inspection logs
• Supporting operator training and compliance procedures
• Reviewing manufacturing processes and identifying improvement opportunities
• Ensuring compliance with ISO standards and medical device regulations
• Supporting documentation updates and quality records management

We would like to hear from you if you have:

• 1–2 years' experience in a Quality Control, Quality Assurance or manufacturing role within medical devices, biotechnology or another highly regulated industry.
• OR substantial cleanroom manufacturing experience and a genuine interest in moving into Quality.
• An understanding of cGMP, cleanroom disciplines within regulated manufacturing environments.
• Strong attention to detail and excellent organisational skills.
• Good written and verbal communication skills.
• Experience using Microsoft Office applications, particularly Excel and Word.
• A positive attitude and willingness to learn.
• Full right to work in the UK status - no visa sponsorship available
• Experience within a medical device manufacturing environment
• Knowledge of ISO 9001, ISO 13485, MDR/MDD regulations, and QMS systems
• Understanding of LEAN principles and continuous improvement
• Strong communication and organisational skills
• Ability to work to deadlines
• Awareness of the Health and Safety at Work Act 1974