QC Manager

TN United Kingdom; Gateshead; On-site; GBP 40,000 - 70,000; Full time

Job summary

Ein etabliertes Unternehmen im Bereich medizinischer Diagnostik sucht einen QC-Manager, der für die Überwachung der Qualitätskontrolle und der Assay-Abteilungen verantwortlich ist. In dieser spannenden Rolle werden Sie die täglichen Aktivitäten leiten, sicherstellen, dass Produkte den regulatorischen Anforderungen entsprechen, und eng mit internen Abteilungen zusammenarbeiten, um Probleme zu lösen. Wenn Sie eine Leidenschaft für Lebenswissenschaften haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Erfahrung in der Qualitätskontrolle in der Medizintechnik/IVD-Branche.
• Kenntnisse in Elektrophorese und Hämostase.

Responsibilities

• Leitung der täglichen Aktivitäten der Qualitätskontrollabteilungen.
• Überprüfung der Outputs auf Konformität mit Spezifikationen.

Skills

Qualitätskontrolle

Teammanagement

Gute Laborpraktiken

Kommunikationsfähigkeiten

Education

Hintergrund in Lebenswissenschaften

Tools

Software für Elektrophorese

Job description

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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 routine testing, value assignment, review, and authorisation of product release to the market. The role involves continuously monitoring product performance via external quality assessment and liaising with internal departments to support investigations into any issues identified.

Responsibilities:

1. Plan and direct the assay / quality control resources to meet product release and EQA timelines, proactively identifying potential delays and implementing mitigating actions.
2. Investigate and implement corrective and preventative actions for ongoing product issues reported by QC or other sources.
3. Review assay / quality control outputs for compliance with specifications and implement remedial actions if necessary.
4. Present concise and accurate product/department updates to management/executive board as required.
5. Lead cross-departmental meetings, ensuring agendas are followed and outcomes are recorded for regulatory purposes.
6. Develop and apply advanced knowledge of electrophoresis and haemostasis to support quality control activities.
7. Gain and maintain a high level of understanding of software programs used across electrophoresis and haemostasis divisions.
8. Train departmental personnel on practical and theoretical aspects, maintaining up-to-date training records.
9. Manage testing materials, including stock control, to ensure timely testing.
10. Handle human resources tasks such as leave requests, performance reviews, and interviews for new staff.
11. Maintain and create documentation in line with regulatory and market expectations.

Your Background:

• Background in Life Sciences, preferably in Medical Devices/IVD Industry.
• Knowledge of good laboratory practices.
• Experience in Quality Control within Medical Devices/IVD Industry.
• Interest or knowledge in Electrophoresis, Capillary Electrophoresis, and Haemostasis.
• Experience with change requests, non-conformances, and deviations.
• Effective team management skills.
• Flexibility and willingness to go above and beyond.
• Good communication skills with all personnel.