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Job Summary
* Procurement, validation, set-up, and maintenance of metrology and measurement systems/equipment.
* Design and validation of metrology fixtures (GRandR).
* Perform and review QFD (Quality Function Deployment) to support product design, development, and operations.
* Conduct data trend analysis for continuous improvement to meet customer requirements.
* Document metrology system validation via protocols and reports using West procedures.
* Ensure proper calibration of all metrology equipment through auditing, managing, and scheduling calibration with external vendors.
* Train metrology operators, conduct refresher training, and assess competency regularly.
* Maintain documentation aligned with West Contract Manufacturing and West Pharmaceutical Services standards.
* Liaise with customers and suppliers on projects.
* Maintain effective communication internally and externally.
* Perform audits as needed and complete documentation.
* Support operations, development, and quality departments.
* Chair customer meetings reviewing measurement systems, data analysis, and inspection reports.
* Perform additional duties as assigned by supervisor.
* Promote continuous improvement and lean operations culture.
* Adhere to company’s Guiding Principles and Code of Conduct.
Additional Responsibilities
* Manage tensile and torsion measurement equipment (e.g., Zwick, Instron).
* Oversee all phases of validation lifecycle for metrology equipment.
* Manage design and validation documentation to ensure equipment is validated and operational.
* Provide end-user training as needed.
* Manage customer and contractor site visits.
Education
* Minimum NFQ Level 7 Degree in engineering or science-related field.
Work Experience
* At least 3 years in a similar role, preferably in the Medical Device Industry, or
* At least 2 years of technical data review experience in a cGMP laboratory, or
* Minimum 3 years in cGMP pharmaceutical industry.
Preferred Knowledge, Skills, and Abilities
* Training/certification in dimensional measurement (e.g., NPL, AUKOM).
* Knowledge of programming coordinate measuring machines (PC-DMIS, Calypso, Volume Graphics).
* Proficiency in ISO/ASME standards, interpreting engineering drawings, and CAD systems like SolidWorks.
* Experience with calibration procedures and management software.
* Experience with Measurement System Analysis (MSA), Minitab, and statistical packages.
* Knowledge of CT scanning is a plus.
* Strong problem-solving and critical thinking skills.
* Proficient in Microsoft Office and other computer skills.
* Excellent communication and interpersonal skills, detail-oriented, organized, and flexible.
* Understanding of ISO 9001:2000 / ISO 13485 standards.
* Experience in validation documentation, SOPs, Work Instructions, and internal audits.
* Ability to motivate and lead teams.
Travel Requirements
Up to 13 days per year (5%).
Physical Requirements
Sedentary work, involving sitting most of the time, with occasional lifting of up to 10 lbs.
Additional Requirements
* Ability to use standard office equipment.
* Effective communication skills, decision-making, data interpretation, and problem-solving abilities.
* Organizational skills for planning and prioritization.
* Ability to work collaboratively and independently.
* Strong analytical and judgment skills.
* Motivational and leadership qualities.
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