PURPOSE -

The Metrology Engineer is responsible for ensuring metrology and inspection control at the manufacturing site are implemented.

ACCOUNTABILITIES -

The Metrology Engineer is responsible to:

• Define and maintain metrology and calibration strategies.
• Drive improvements to enhance metrology and calibration.
• Create/update procedures for metrology and calibration and ensure they are adhered to.
• Ensure compliance with Quality Regulations, ISO, AAMI standards, and regional requirements.
• Lead investigations of in process inspection incidents, and deviations from calibration and metrology procedures.
• Ensure monitoring related calibration and metrology is performed.
• Analyze and interpret drawings and inprocess monitoring data, identifying trends and implementing corrective actions.
• Act as a metrology and calibration Subject Matter Expert (SME) during routine operations and audits.

Critical Knowledge and Qualifications: (what the role holder must know; including any required general or professional qualifications/education)

• Solid knowledge of regulatory requirements related to calibration and metrology or ability to rapidly develop expertise to function independently with minimal supervision.
• ISO 13485 (Quality Management System for Medical Devices)
• Minimum Bachelor’s degree in in a relevant scientific discipline
• Solid expertise in statistical data analysis
• Beneficial 2+ years of experience in the field of calibration or metrology in the medical device or pharmaceutical industry
• Knowledge and understanding in use of inspection equipment, gages and gaging.
• Have at least a basic understanding and operation of automated inspection equipment (ie. video systems, cmm).
• Knows how to use CAD system preferably AutoCad
• Be able to create gages or fixturing to hold parts on inspection equipment.

CRITICAL SUCCESS FACTORS AND KEY CHALLENGES – additional factors that describe complexity of the role / critical requirements for successful role performance

• Able to drive improvement projects simultaneously
• Able to implement test method validation procedures, that describe process adequately and are regulatory compliant as well as efficient use of resources
• Able to assess the impact of manufacturing changes (e.g equipment, process, material and environmental changes) on calibration and metrology
• Author, revise, and review technical and procedural documentation related to calibration and metrology practices