Quality Assurance Manager, £50-60k, Cambridge, IVDs

Recruiter
Meet Recruitment Ltd
Location
Northampton
Salary
£50-60k
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
The QA Manager for this exciting IVD company will be responsible for establishing and maintaining an effective Quality Management System in accordance with relevant standard. They will also be responsible for interacting with and representing the company to the Regulatory and Notified bodies in the key territories (UK, EU, US) and lead the process of obtaining accreditations, certifications and other regulatory approvals.

QA Manager, IVDs, Cambridge, £50-60k

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.

Overview of Key Duties and Responsibilities

- Management of the Document Control System ensuring all documents are held securely and readily available
- Management of QA Systems including CAPA, Change Control and Design Control
- Support all Risk Management activities
- Manage the validation and calibration program for equipment/laboratory computerized systems/software to ensure fitness for purpose.
- Lead the business in problem resolution and root cause analysis methodology in order to identify corrective and preventive actions and minimise the risk of (re)occurrence
- Manage the internal audit program to ensure compliance with the QMS and identify areas for improvement
- Manage the supplier qualification program to ensure purchased materials and out-sourced services are to the appropriate quality
- Engage with all departments and functional groups within the company to ensure that they are fully engaged with the Quality Management Systems

Key Skill Required:

- QA Experience in a regulated environment (GCLP, ISO15189, ISO17025, ISO13485 or similar US regulations CLIA, CAP etc.)
- Understanding of the requirement to achieve ISO 17025
- Familiar with the requirements of UK Human Tissue Act (HTA)
- Familiar with Risk Management Tools (eg. FMEA)
- Quality Management Training/Lead auditor certification

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