QA Manager | Competitive | Sunderland, UK

This prestigious, leading, and well-established medical diagnostic company comprises two flagship business divisions that specialise in the design, manufacture and continued support of Haemostasis systems and Clinical Electrophoresis equipment.

The QA Manager will oversee the release of all products manufactured across both business divisions in the North-East. Furthermore, the QA Manager will assist with the maintenance of the QMS to ensure all medical devices sold are compliant within local/ national regulations. You will also be responsible for the quality of the products and that this is managed throughout product development and the manufacturing process.

Key responsibilities:
1. To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use, and to make the documents effective, where outside Q-Pulse if required.
2. To act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
3. To assist with the maintenance of the site Quality Management System, including updating of documentation and providing training where necessary, including occasional Q-Pulse induction training.
4. Owner of the site NC/CAPA process to ensure the quality of the product is maintained.
5. To work with the regulatory, quality control and production teams to ensure product requirements are met prior to release to the market.
6. Work closely with the Quality Control Manager and Regulatory Affairs Manager to ensure product is released to the market only if quality and regulatory requirements are met.
7. To maintain high levels of integrity and regulatory compliance.

Key Skills Required:
• At least 2 years’ experience and background in medical device or pharmaceutical quality assurance at a management level.
• Knowledge and experience of Quality Management Systems
• Sound working knowledge of Good Manufacturing Practices (GMP)
• Design and preparation of Standard Operating Procedures (SOP).
• Review and approval of compliance of company production and QC documentation.
• Competent in the use of the Internet and Microsoft Windows programs including Word, Excel and Power Point.
• Able to organise and manage multiple projects and priorities.
• Ability to identify problems and implement changes to address them.

If you like the look of this role but you’re hesitant to apply because you don’t meet all of the necessary skills, then I’ll encourage you to apply anyway. We’re looking for someone to grow and learn on the job, which can’t really happen if you already know everything.

Tagged as: CAPAs, Medical devices, Quality, Quality Assurance