The Metrology Specialist is responsible for the oversight and/or calibration, and maintenance of analytical equipment as well as providing support for lab related facilities functions. With regard to technical competence, the Metrology Specialist is expected to be able to program and run the CMM and Vision system. In addition, the Metrology Specialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a plastics testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations.
Primary Responsibilities:
The Metrology Specialist also participates in the resolution of any equipment problems that may arise during laboratory testing and engages in the process whereby key department documents such as equipment SOPs and worksheets and forms are developed, reviewed, and approved. This position also requires skills at investigation of Out-of-Tolerance events, impact assessments, and the management of equipment systems in the laboratory.
Maintain equipment readiness so that all reasonable customer requests pertaining to the conduct of testing are met in a timely and effective manner.
Execute FAI and PPAP data measurements reports for customer samplings.
Training of quality personnel on created programs for the CMM and vision system.
Maintain equipment within established parameters governing regulatory compliance expectations.
Assist in the interpretation of calibration records requested by customers during on-site audits. Participate in customer audits as directed by Quality Management.
Participate in department and/or company-wide projects designed to improve the nature of customer service.
Lead in the resolution of Out-of-Tolerance events.
Assist Management in addressing and resolving Corrective or Preventive actions as they relate to measurements
Ensure that all reasonable requests from department management pertaining to laboratory testing equipment are met in a timely and effective manner.
Ensure that staff working in the laboratory receive the help and cooperation they need on equipment usage to successfully complete their studies.
Lead gage R and R studies , CPK and DOE efforts with regards to measurement preparations and studies.
Prepare protocols related to validation and requalification of product and ensure all schedules are being maintained.
Coordinate outside calibration testing for equipment as needed and maintain IQMS calibration due dates.
Ensure all equipment documentation is complete, up-to-date, and stored properly.
Play a key role in creating and maintaining an atmosphere of teamwork within the metrology team.
Provide updates to Quality Management concerning in process projects related to equipment.
Maintain thorough knowledge and understanding of all Standard Operating Procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance.
Maintain thorough knowledge and understanding of general SOPs, GMP/GLP and ISO regulations as it pertains to work performed in the laboratory.
Participate in the preparation and review of appropriate department SOPs, worksheets, and data forms.
Education, Required Skills & Competencies:
BA/BS in a scientific field or equivalent job experience required.
Recommended at least two years relevant laboratory experience in a regulated environment and dealing with analytical and general laboratory equipment, PC-DMIS.
Must be able to think analytically; problem solving skills are essential.
Ability to interpret part prints, quality plans, work instructions, and apply the knowledge appropriately
Ability to develop and write technical documents and train personnel
Proficient in use of Office software including word processing, Minitab, and spreadsheets
Ability to generate, read and interpret statistical reports
Must possess excellent written, verbal, and interpersonal communications skills to interact within all levels of the organization
Demonstrated experience in formalized problem solving
Physical Demands:
Extended hours sitting/standing, repetitive hand and wrist movements.
Standing, sitting, walking, bending, stooping, crouching, kneeling, lifting up to 50 lbs. occasionally.
Work Environment:
Manufacturing environment with associated noises, smells and temperatures
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