Description
My client is now looking for a QA/RA Manager - Medical devices (55,000) to join their vibrant Surry based team.Duties & responsibilities;
These will include the following listed below and other duties may be assigned depending on the needs of the business:
- In conjunction with the QA & RA Director, organise, develop and maintain the Company QA/RA activities in accordance with the Company Quality Assurance system and ensure all members of staff are familiar with and comply with such requirements
- Deputise for the QA and RA Director where permitted by procedures including acting as the Deputy Management Representative as defined in ISO13485 and 21CFR820
- Work with the QA & RA Director to maintain a full accreditation under current and foreseeable EU and FDA Directives for medical devices related to orthopaedics, as necessary
- Plan and manage all internal and external audit processes both by and of the Company
In line with documented procedures:
Manage
- Day to day document control activities and report any issues to the QA & RA Director
- Workload and project-manage each project in conjunction with other departments including projected deadlines
- Quality Management System
- CAPA system
- Complaints system including monitoring, acting upon and closing all customer complaints in a timely manner and reporting to the QA & RA Director and MHRA when necessary
- Supplier approval, audit and monitoring system.
- The Quality Engineer's activities and ensure they are aligned to the department's goals and objectives.Skills & Experience;
- Strong Quality Assurance background - preferably in the medical industry
- IRCA Lead auditor to 13485
- Thorough understanding of CE marking, EU device directives and FDA
- Working with the FDA
- Working knowledge of Microsoft Office
Desirable;
- Implant manufacturer background
- Regulatory experience
- Line management experience
- Report writing skills
My client is looking to move quickly on this so if you think you have the required skill sets then please send me your CV and I will be in touch shortly.