Title:  Metrology Engineer

Job Summary

In this role, you will be is responsible for all metrology related activities. Central to this role will be the responsibility for implementing new measurement technologies to ensure West Contract Manufacturing are industry leaders for measurement technology. 

Essential Duties and Responsibilities

• Procurement, validation, set-up and maintaining metrology and measurement systems/equipment.
• Metrology fixture design and validation (GRandR)
• Perform and review QFD (Quality Function Deployment) in support of product design, development and operations.
• Conduct data trend analysis to identify short and long-range patterns so that recommendations can be made to effect continuous improvement necessary to satisfy customer requirements.
• Document metrology system validation via protocols and reports using West procedures
• Ensures that all metrology equipment is correctly calibrated through auditing, managing and scheduling the calibration of inspection equipment through external vendors.
• Training of metrology operators, ongoing re-fresher training and assessment to determine level of competency on a frequent basis.
• Establish and maintain documentation in line with West Contract Manufacturing and West Pharmaceutical Services.
• Liaise with customers and suppliers on new and existing projects.
• Maintain good communications both internally and externally.
• Makes periodic audits as requested and completes necessary documentation.
• Support to operations, development and quality departments.
• Chairing customer meetings reviewing measurement systems, data analysis and first article inspection reports.
• Perform additional duties at the request of the direct supervisor.
• Drives a culture of continuous improvement and lean operations.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Other duties as assigned.

Additional Responsibilities

• Take full ownership of tensile and torsion measurement equipment, eg. Zwick, Instrom etc. 
• Assume responsibility for the Metrology equipment throughout every phase of the validation lifecycle, from installation to validation and onto operations. 
• Manage all design and validation documentation, ensuring the equipment is in a validated and operational state at all times. 
• Provide end user training as required. 
• Manage Customer and Contractor site visits as necessary. 

Education

• Must have a minimum of a NFQ Level 7 Degree in an engineering or science related field. 

Work Experience

• Minimum 3 years of experience in a similar role, ideally in the Medical Device Industry; or 
• Minimum 2 years of technical data review experience in cGMP laboratory; or
• Minimum 3 years’ experience in cGMP pharmaceutical industry

Preferred Knowledge, Skills and Abilities

• Training/certification in dimensional measurement preferred. (i.e. NPL, AUKOM)
• Knowledge of programming coordinate measuring machines is essential using software like: PC-DMIS, Calypso, Volume Graphics.
• Proficient knowledge of ISO/ASME GDigital and Transformation requirements, interpreting 2D engineering drawings and 3D models for various levels of medical device components, assemblies, and subassemblies using CAD system (e.g. SolidWorks).
• Knowledge and experience with in-house calibration procedures and calibration management software including day to day inspections of equipment.
• Proven experience of Measurement System Analysis (MSA) development, Minitab and statistical packages is essential.
• (i.e. Measurlink)
• CT scanning knowledge would be a distinct advantage.
• Strong problem solving and critical thinking skills to troubleshoot issues and identify root causes.
• Computer literacy required including all Microsoft Office utilities.
• Must possess good communication/interpersonal skills; must be detail orientated, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.
• Working knowledge of ISO 9001:2000 / ISO 13485.
• Knowledge of generating validation documentation and subsequent reporting
• Knowledge of generating Standard Operating Procedures and Work Instructions
• Knowledge of Internal Quality and Systems Auditing.
• Ability to motivate a team toward a common goal.
• Ability to work, lead and empower team members

Travel Requirements

Physical Requirements

Additional Requirements

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets.
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyse and solve problems
• Strong problem solving and critical thinking skills to troubleshoot issues and identify root causes.
• Computer literacy required including all Microsoft Office utilities.
• Ability to successfully utilize influence to motivate a team toward a common goal
• Drives a culture of continuous improvement and lean operations.