QC Manager

CK Group are recruiting for a QC Manager on behalf of a medical diagnostic company to be responsible for the management of the quality control and assay departments spanning haemostasis, gel electrophoresis and capillary electrophoresis divisions. This role is based at the Sunderland and Gateshead sites. It is a permanent role with Mon-Fri day time working hours.

The Role:

To manage the day-to-day activities of the various quality control and assay departments in respect of the routine testing, value assignment, review and authorisation of product release to the market while continuously monitoring product performance via external quality assessment and liaising where appropriate with internal departments to support investigations into any issues identified.

Responsibilities:

• To plan and direct the assay / quality control resource to meet the required product release and EQA timelines and be proactive in identifying potential delays and implementation of mitigating actions.
• To provide first line investigation of and corrective and preventative actions to ongoing product issues reported by QC or other relevant sources.
• To review the output of the assay / quality control scientists for compliance with agreed specifications including implementing remedial actions where the output is not acceptable.
• To present concise and accurate product / departmental updates to the management / executive board as required.
• To lead cross departmental meetings ensuring agenda is followed and outcomes/responsibilities are appropriately recorded for technical regulatory purposes.
• To develop, maintain and apply a high level of theoretical electrophoresis and haemostasis knowledge to support quality control activities.
• To develop a high level of knowledge of the features and workflow of required software programs across the electrophoresis and haemostasis divisions.
• To train departmental personnel on both practical and theoretical areas of expertise and ensure maintenance of up-to-date training files.
• To maintain control of testing materials including appropriate stock control activities to ensure timely and appropriate testing.
• To undertake required human resources tasks such as annual leave requests, routine personnel reviews / performance management reviews and interviews for new personnel.
• To drive the maintenance and creation of documentation (both departmental and product specific) in line with regulatory and market expectations.

Your Background:

• Good Life Science background, preferably in the Medical Devices/IVD Industry.
• Good laboratory practice.
• Quality Control experience, preferably in Medical Devices/IVD Industry.
• Sound knowledge/interest in Electrophoresis, Capillary Electrophoresis and Haemostasis.
• Experience in raising/approving/actioning change requests and raising/actioning non-conformances and deviations.
• Ability to effectively manage a team of experienced personnel.
• Flexible with the willingness to go above and beyond.
• Able to communicate well with all personnel within the company.

Apply:

It is essential all applicants hold entitlement to work in the UK. Please quote job reference 132 166 in all correspondence.