Senior Quality Specialist, Kent, £DOE, Medical Devices, IVDs

Recruiter
Meet Recruitment Ltd
Location
Gravesend
Salary
£35-40k
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Would you like the opportunity to work for an industry leading medical device company? They are looking to bring on a QA Specialist who has the ability to mentor and deputise for the QA Manager when required. With a focus on product release and coordinating investigations, the successful candidate will be self-assured when it comes to Quality.

Senior Quality Specialist, Kent, £DOE, Medical Devices, IVDs

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

General Responsibilities:

- Ensure compliance to external (regulatory) requirements, including Quality Management Systems: ISO 13485, Quality Systems Regulation, MDR/IVDR).
- Maintain compliance to the requirements of site's Quality System and ensuring the Quality Assurance team meets the QMS objectives for the site.
- Responsible for reviewing and approving quality documents in line with local quality procedures.
- Undertake QA responsibilities regarding failure investigations, hold and recall investigations, risk assessments and field actions, ensuring all necessary review are timely documented and completed.
- Perform internal audit to ensure compliance to external regulatory requirements.
- Assist with mentoring and leading a small team of Quality Assurance professionals.
- Lead in the role of Risk Management and PMS; with knowledge of ISO14971.
- Deputise for the Quality Manager in their absence.

Skills preferred:

- Experience within medical devices; ISO 13485
- Experience with rick management; ISO 14971
- Post Market Surveillance
- Continuous Improvement

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at: *************************** and **********************************-berkley-a25811139/