Quality Control Laboratory Manager

ZipRecruiter; Sunderland; On-site; GBP 40,000 - 60,000; Full time

Job summary

An established industry player is seeking a QC Manager to oversee quality control and assay departments in a dynamic medical diagnostic environment. This role involves managing daily operations, ensuring compliance with regulatory standards, and leading a team to enhance product quality. The ideal candidate will have a strong background in life sciences, particularly within the Medical Devices/IVD sector, and will be adept at communication and team management. Join a forward-thinking company that values innovation and quality, and make a significant impact on the healthcare landscape.

Qualifications

• Strong life science background, preferably in Medical Devices/IVD Industry.
• Knowledge of good laboratory practice and quality control.

Responsibilities

• Manage daily activities of quality control and assay departments.
• Investigate product issues and implement corrective actions.

Skills

Quality Control

Electrophoresis

Good Laboratory Practice

Team Management

Communication Skills

Education

Life Sciences Degree

Tools

Laboratory Software

Job description

Job Description

CK Group is recruiting for a QC Manager on behalf of a medical diagnostic company. The role involves managing the quality control and assay departments across haemostasis, gel electrophoresis, and capillary electrophoresis divisions. This is a permanent position based at the Sunderland and Gateshead sites, with Mon-Fri day hours.

The Role:

Manage daily activities of the quality control and assay departments, including routine testing, value assignment, review, and product release. Monitor product performance via external quality assessment and liaise with internal departments to support investigations into issues.

Responsibilities:

1. Plan and direct assay/quality control resources to meet product release and EQA timelines, proactively identifying delays and implementing mitigation.
2. Investigate product issues reported by QC or other sources and implement corrective/preventative actions.
3. Review assay/quality control outputs for compliance with specifications and implement remedial actions if needed.
4. Provide concise updates to management and the executive board.
5. Lead cross-departmental meetings, ensuring agendas are followed and outcomes are documented for regulatory purposes.
6. Develop and maintain expertise in electrophoresis and haemostasis to support QC activities.
7. Gain knowledge of software workflows across divisions.
8. Train personnel on practical and theoretical aspects, maintaining training records.
9. Control testing materials and manage stock to ensure timely testing.
10. Handle HR tasks such as leave requests, personnel reviews, and interviewing new staff.
11. Maintain and create documentation aligned with regulatory and market standards.

Your Background:

1. Strong life science background, preferably in Medical Devices/IVD Industry.
2. Knowledge of good laboratory practice.
3. Experience in Quality Control within Medical Devices/IVD.
4. Interest and knowledge in electrophoresis, capillary electrophoresis, and haemostasis.
5. Experience in managing change requests, non-conformances, and deviations.
6. Ability to lead and manage a team effectively.
7. Flexible and willing to go above and beyond.
8. Excellent communication skills across all levels of personnel.

Apply:

Applicants must have entitlement to work in the UK. Please quote job reference 132166 in all correspondence.