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