Quality Control Manager

2 days ago

North Yorkshire, United Kingdom Real Staffing Full time

**Quality Control Manager - Medical Devices**

Our client is a medical device company who operate globally in over fifty countries and are currently hiring for their site in North Yorkshire. They develop and manufacture solutions and partner with medical professionals to improve patient care and clinicaloutcomes.

**Position**

The Quality Control Manager is responsible for the overall management of the raw material acceptance, in process quality control and batch release processes, the quality control team and key support processes including; raw material and product non conformance,supplier management; change control, document management, archiving and environmental monitoring.

The QC Manager also actively supports the maintenance and development of the Quality Management (QMS) and Labour Standards Assurance Systems (LSAS), providing training and mentoring as required to drive quality compliance across the company.

**Responsibilities**
- Leadership, management and development of the Quality Control Team.
- Planning, scheduling and completion of raw material acceptance in process control and batch release activity to meet production and delivery schedules.
- Management of the internal and external non conformance process.
- Effective control of non-conforming materials and product
- Management of supplier approval and ongoing suitability assessment.
- Management of the change control system and to ensure timely closure
- Management of the document control system and archiving process
- Ownership of customer complaints and quality issues ensuring effective investigation, CAPA implementation & verification to determine root cause and prevent re-occurrence.
- LSAS maintenance and improvement
- Quality system maintenance and development
- Compilation and monitoring of quality system and product quality and process capability metrics
- Auditing to ISO 13485 and FDA 21 CFR Part 820
- Production support inc. maintenance of clean room environment, environmental analysis etc

**About You**
- Knowledge of US FDA, EU Medical Device regulations
- Ideally a Scientific background
- Ideally a Lead Auditor

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

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