CK Science are currently recruiting for a Quality Engineering Manager to join a Medical Device company with sites in the south of the UK, to provide device Quality representation on development projects/programmes to ensure compliance with relevant regulatory standards.
As Quality Engineering Manager, you will also be expected to provide the Quality function in the review of device related documentation and other quality system related activities.
Key responsibilities will include:
- Evaluating proposed new suppliers (by audit) for use with device programmes.
- Providing guidance, support and information to project colleagues on device quality issues.
- Logging and co-ordinating responses to customer complaints.
- Working with existing suppliers to ensure project quality goals are met.
- Ensuring the timely audit of current device approved supplier list.
- Providing Device Quality representation during customer/regulatory body visits/audits.
- Managing device Quality activities of the Quality Scientist.
- Reviewing device supplier devices and device component BMR’s for use in Clinical Trials.
- Ensuring client Quality activities are managed and met appropriately.
As Quality Engineering Manager, you will also be responsible for proposing what decisions should be made within the section and what needs to be referred. You will be able to make decisions within your own function, under pressure including unpopular decisions and will be able to prioritise your own and others activities to achieve deadlines.
The role will be 80% office based and 20% Inter-site based so travel between sites will be required
The ideal candidate will hold a degree (or equivalent) in an appropriate Science or Engineering discipline and will have worked for Pharmaceutical and/or Medical Device companies or a similarly regulated Engineering company. It is essential that they have substantial experience gained from previous roles, one of which should have been in a Medical Devices role.
The ideal candidate will be proactive in providing innovative solutions and evaluating alternatives, will be able to apply a systematic/logical approach taking in to account information from a variety of sources and will be able to deal with complex problems. Quality Management experience is essential and it will be expected that you will be the “expert” others will go to.
Excellent communication skills are essential as you will be presenting complex information and concepts in a way that is simple and easy to understand and you will also promote new strategies and ensure practical policies, procedures and business direction are implemented.
For more information or to apply for this Quality Engineering Manager position, please contact Jason Johal at CK Science on 01438 723 500 or email firstname.lastname@example.org. Please quote reference ST21867 in all correspondence.