Quality Management Systems / CAPA Specialist

Cpl Healthcare; Gloucester; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading Medical Device Manufacturer is seeking a Quality Management Systems (QMS) specialist. This role involves managing the internal audit program, supporting ISO 13485 compliance, and driving continuous improvement initiatives. Candidates should have experience in Quality Systems, preferably in the Medical Devices industry, and possess strong communication skills.

Qualifications

• Experience with Quality Systems is essential.
• Experience in the Medical Devices industry is highly desirable.

Responsibilities

• Manage the internal audit program and perform internal audits.
• Provide support during external audits and manage Quality Objectives.
• Support continuous improvement initiatives.

Skills

Quality Systems

Communication

Tools

Microsoft Office

Job description

Our client, a leading Medical Device Manufacturer, is looking to appoint a Quality Management Systems (QMS) specialist responsible for managing the internal audit program. The role supports the implementation and maintenance of the ISO 13485 certified Quality Management System across the company, including Quality Objectives, NC/CAPA management, and monitoring, measuring, and reporting on QMS performance.

Responsibilities of the Role:

1. Manage the internal audit program, including scheduling audits and assigning auditors.
2. Perform internal audits as assigned.
3. Provide support during external audits, including collating pre-audit document requests.
4. Manage the Quality Objectives procedure.
5. Manage the NC/CAPA procedure.
6. Provide backup/support for document control and training activities on MasterControl.
7. Provide training to team members/colleagues as required.
8. Support continuous improvement initiatives by leading or participating in projects.
9. Ensure adherence to health & safety responsibilities as per company policy and legal requirements.

Qualifications and Experience:

1. Experience with Quality Systems is essential.
2. Experience in the Medical Devices industry is highly desirable.
3. Proficiency in Microsoft Office (Word, Excel, OneDrive).
4. Excellent written and oral communication skills in English.