Our client is a leading developer and manufacturer of medical devices organisation based in the South West area.
The role involves managing the compliance requirements through the Quality Management System, including continuous improvements, managing documents, CAPA management quality planning, as well as internal and external audits, validation and risk management
Key Responsibilities
Support and improve the site's quality management system to comply with MDR, MDSAP regulations, and Group procedures. Execute and implement quality strategies successfully. Ensure the quality team is well-trained and motivated. Manage the budget for the site quality function and act as the Management Representative when required.
The Quality Manager will be an integral member of the Operations Management team, responsible for establishing and overseeing quality improvement projects that align with company objectives. This role includes supporting the effective delivery of new product development (NPD) and ensuring that NPD products meet design control and validation requirements. The Quality Manager will continuously improve the quality management system, make decisions on quality issues, conduct root cause analyses, implement corrective actions, and work to prevent product recalls. Additionally, the Quality Manager will maintain the quality management system certification.
The successful candidates will have:
- BSc or equivalent in a scientific discipline with at least 4 years' experience in medical device or pharmaceutical industries and demonstrated leadership quality
- Proficient in Quality System Regulations, ISO requirements, and Medical Device regulations
- Knowledgeable in QA, Manufacturing, Validation, Change Control, and Design Control processes
- Skilled in spreadsheets, word processors, statistics, sampling plans, and statistical analysis
- Experienced in analytical methods, equipment, process, software, and validations
- Capable of independently planning and solving moderate to complex issues
- Good judgment in selecting methods and techniques for solutions
- Strong oral and written communication skills
- Ability to manage multitask multiple projects
- Computer literate in Word, PowerPoint, and Excel
To apply for this position, candidates must be living in the UK and eligible to work.