Quality Manager, Medical Devices
3 days ago
Daray Ltd are recruiting for an experienced individual into the position of Quality Manager who will be responsible devising, establishing and maintaining quality procedures, processes, standards and specifications in relation to ISO 13485, ISO 9001 andMedical Device Regulations.
DARAY has been designing and manufacturing specialist lighting since 1968. A privately-owned British company based in Derbyshire. DARAY has continued to expand on their product range and produce a comprehensive range of medical lights including operatingtheatre, examination and patient lighting to support the needs of medical professionals.
**Main Duties**
- Lead Quality System function by ISO 13485 and any other quality and regulatory requirement in medical devices.
- Responsible for the maintenance and development of the QMS.
- Oversee general day-to-day QA activities including document control, change control, supplier control activities, batch release activities and customer complaints.
- Management of the internal audit schedule.
- Ensure products are manufactured to meet all defined specifications and are developed and manufactured to comply with all applicable quality system requirements.
- Management level experience with knowledge of international quality systems, including ISO 13485 and 9001.
- Medical Device experience essential including understanding of associated regulations.
- Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, audits, and risk management among others).
- Strong interpersonal and communication skills with the ability to convey a compelling vision and sense of core purpose.
- A willingness to get involved on critical tasks
- The ability to work on their own as well as taking direction from others but most importantly to manage their time effectively;
- Exhibiting self-motivation and a proactive approach to all duties under this role.
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