Calibration and Metrology Specialist
1 week ago
OBJECTIVE -
The Calibration and Metrology Specialist is tasked with overseeing the implementation of metrology and inspection controls within the manufacturing environment.
RESPONSIBILITIES -
The Calibration and Metrology Specialist is accountable for:
- Establishing and sustaining metrology and calibration protocols.
- Driving enhancements to optimize metrology and calibration processes.
- Developing and revising procedures for metrology and calibration, ensuring compliance.
- Maintaining adherence to Quality Regulations, ISO standards, AAMI guidelines, and local mandates.
- Leading investigations into inspection incidents and deviations from established calibration and metrology practices.
- Ensuring that calibration and metrology monitoring activities are executed effectively.
- Analyzing and interpreting technical drawings and monitoring data, identifying trends, and implementing corrective measures.
- Serving as a Subject Matter Expert (SME) in metrology and calibration during routine operations and audits.
Essential Knowledge and Qualifications: (requirements for the role holder, including necessary qualifications and education)
- Thorough understanding of regulatory standards related to calibration and metrology, or the ability to quickly acquire the necessary expertise to operate independently.
- Familiarity with ISO Quality Management Systems for Medical Devices.
- A minimum of a Bachelor's degree in a relevant scientific field.
- Strong proficiency in statistical data analysis.
- Preferred 2+ years of experience in calibration or metrology within the medical device or pharmaceutical sectors.
- Knowledge of inspection tools, gauges, and gaging techniques.
- Basic understanding and operation of automated inspection technologies (e.g., video systems, CMM).
- Proficient in CAD software, preferably AutoCAD.
- Ability to design gauges or fixtures for inspection equipment.
KEY SUCCESS FACTORS AND CHALLENGES – additional elements that outline the complexity of the role and critical requirements for effective performance
- Capable of managing multiple improvement projects concurrently.
- Able to implement validation procedures for test methods that are both compliant with regulations and efficient in resource utilization.
- Skilled in assessing the implications of manufacturing modifications (e.g., equipment, processes, materials, and environmental changes) on calibration and metrology.
- Competent in authoring, revising, and reviewing technical and procedural documentation related to calibration and metrology practices.
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