|Job Ref:||204806239||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||Cambridgeshire||City:||Cambridgeshire||Address:||Post Code:||CB1||Salary:||£50000 - £60000/annum Benefits||Post Date:||18/10/2016 03:01|
Austin Fraser are again, excited to be representing one of the major players in the Global Medical Device industry. Our client are known for their highly innovative work around the world and for this reason continue to grow at an outstanding rate in the UK at both their head manufacturing facility and specialist R&D centre.|
The position on offer is a Quality Management position at their R&D facility close to Cambridge as part of a creative cross functional team who provide expert advice to clients at the initial phase of the product lifecycle. The environment is fast paced, and highly exciting at the forefront of technology.
You responsibilities will include:
* Continue to drive the implementation and improvement of the Quality Manual and associated procedures
* Lead the regulatory strategy and dossier compilation & management for parenteral products/combinations.
* Lead the internal auditing process
* Champion the proactive management of key Innovation suppliers from a quality perspective; ensuring the needs of projects and QMS are maintained and continuously improved.
* Assume responsibility for the day to day management and maintenance of the QMS
* Host quality audits from both our regulatory body and customers
* Carry out training on quality procedures/processes for the Innovation team and develop Quality training material for new starters
* Support and guide the Risk Management process and Validation Master Plan for projects
* Lead the introduction of quality considerations for low volume manufacturing; implementing the procedures that exist and driving improvements as necessary.
It is essential that you have extensive experience working with ISO 13485 and ISO 14971 and any drug delivery or injection moulding experience would be highly desirable