Project Quality Engineer

JR United Kingdom; Worcester; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading company in the design and manufacture of high-class III medical devices is seeking a Quality Associate for a 3-month contract. This role involves supporting the ISO 13485 Quality Management System and ensuring compliance across various functions, from product testing to terminal sterilisation. The ideal candidate will have experience in a regulated QMS environment and strong communication skills.

Qualifications

• Experience in a regulated QMS environment, ideally ISO 13485.
• Understanding of medical device manufacturing and quality assurance processes.
• Strong communication and documentation skills.

Responsibilities

• Support internal and external audits.
• Manage document control and CAPA activities.
• Maintain and update Quality System documentation.
• Assist with product and process validation reviews.
• Liaise with subcontractors and manufacturing teams.

Skills

Communication

Documentation

Quality Assurance

Job description

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Sector: Medical Devices / Quality Assurance

About the Role:

Our client, a leader in the design and manufacture of high-class III medical devices, is seeking a Quality Associate for a 3-month contract. This role will support the ongoing maintenance and development of the ISO 13485 Quality Management System (QMS) and ensure compliance across various functions, from product testing to terminal sterilisation.

Key Responsibilities:

• Support internal and external audits
• Manage document control and CAPA activities
• Maintain and update Quality System documentation
• Assist with product and process validation reviews
• Liaise with subcontractors and manufacturing teams

About You:

You should have previous experience within a regulated QMS environment, ideally ISO 13485, and a good understanding of medical device manufacturing and quality assurance processes. Strong communication and documentation skills are essential.

We are looking for someone who is available to start immediately.