Quality Product Associate – Medical Devices - #2089732
MEDASIL SURGICAL LIMITED
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.
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
Desirable Skills & Experience
· 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
· Experience using SharePoint
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