Quality System Manager - Medical Devices

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Job description

TEC Partners are pleased to be working with a well-funded point of care diagnostics business who are addressing how molecular diagnostics will have an impact on how infectious disease are managed at a point of care.

Quality Systems Manager Role:

As Quality Systems Manager you will be responsible for managing all aspects of the quality systems and ensuring system regulatory compliance for the company's emerging IVD initiatives. You will be liaising with auditing organisations, notified bodies and regulatory authorities where necessary. Responsible for reporting performance measures for quality improvements and compliance as well as providing knowledge and support to the company to enable operation of manufacture within regulatory guidelines.

Quality Systems Manager Responsibilities:

Representative for the quality management systems
Ensure awareness of compliance to regulatory and customer requirements
Ownership CAPA, change and quality event system
Implementation of training programmes
Responsible for the compliance and maintenance of the QMS
Managing audit programmes (internal, supplier, certification, notified bodies)
Maintenance of eMQS

Quality Systems Manager Requirements:

Experience of quality management, quality assurance or quality systems leadership in the medical device sector
Master's degree (emphasis of health sciences or relevant technical field)
Demonstratable knowledge and understanding of quality systems
Proven experience of process, procedure and quality systems development
Thorough understanding of the latest versions of applicable medical device standards including ISO 13485, 14971 and FDA quality system regulations
Experience with electronic quality systems software as system administrator

Quality Systems Manager Desirable:

Structured, self-motivated and passionate about quality
Result oriented individual who is comfortable dealing with cross-functional teams
Strong communication skills and the ability to work with internal and external authorities
Attention to detail
Experience with Dot and QMS software is a plus

In return, you'll receive an attractive salary and benefits package, which includes generous holiday allowance, excellent company pension, bonus and private health care.

If you possess the skills and experience required, submit a copy of your CV straight away to be considered