Job Title: Calibration Manager
Location: Oxford, UK (onsite)
Job Type: Permanent
Calibration Manager
The Calibration Manager is responsible for overseeing daily calibration activities across the UK, EU, and US operations. This role ensures that all mechanical and electrical equipment is properly calibrated and ready for use, supporting various business functions, including the service center, incoming inspection, manufacturing, and engineering teams.
The position involves planning, executing, and documenting all calibration activities for the organization’s calibrated equipment, as well as managing the calibration process on an ongoing basis. The Calibration Manager will report directly to the Senior Manager of Inbound Quality and will work closely with all relevant departments impacted by calibration requirements.
This is a flexible but on-site role based in the Oxford office to ensure effective control of manufacturing and service documentation, as well as collaboration with global Operations and Quality teams. The working arrangement will be agreed upon with the Senior Manager, Inbound Quality.
Key Responsibilities
* Managing all aspects of daily calibration activities.
* Supporting the implementation and maintenance of the global calibration system (Blue Mountain RAM or equivalent).
* Administering calibration software, defining, and developing related processes and procedures.
* Coordinating calibration requirements across UK, EU, and US operations.
* Maintaining calibration records and generating required reports.
* Ensuring calibration activities are performed within required timelines.
* Leading initiatives to improve the performance of the calibration system.
* Acting as a Subject Matter Expert by maintaining knowledge of regulatory requirements and participating in customer audits.
* Conducting monthly reviews to ensure all equipment is accounted for in the calibration system.
* Identifying nonconformities and assessing their impact on devices.
* Leading and supporting investigations and documentation related to calibration nonconformities.
* Supporting internal, regulatory, and FDA audits, ensuring audit readiness.
* Conducting statistical trend analysis of testing data.
* Ensuring adherence to Standard Operating Procedures (SOPs), Work Instructions, and calibration specifications.
* Completing other tasks as assigned by the Senior Manager, Inbound Quality.
* Complying with the organization's Code of Conduct and company policies.
Skills & Experience
* Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) requirements.
* In-depth understanding of calibration standards and procedures.
* Strong ability to create and write SOPs, Work Instructions, and specifications.
* Proven experience in implementing and managing a global or multi-site calibration database.
* 5 to 10 years of experience in the medical device, pharmaceutical, or life sciences industries.
* Familiarity with calibration systems, particularly Blue Mountain RAM or similar.
* Knowledge of SAP or similar Enterprise Resource Planning (ERP) systems (desirable).
* Experience with MasterControl or similar electronic Quality Management Systems (eQMS) (desirable).
* Strong problem-solving skills.
* Excellent written and oral communication skills.
* Understanding of GMP compliance requirements in Quality Control.
* Attention to detail and accuracy.
* Ability to foster a collaborative working environment.
* Comfort in fast-paced, evolving work environments with a high level of adaptability.
#J-18808-Ljbffr