About this role
Metrology Technician: • Assist Engineers with tasks related to measurement method development and support in compliance with quality regulations for medical device manufacturing • Setup and conduct test method validation for variable and attribute test method validation activities, including sample creation, developing test method work instructions • In coordination with site the quality team, calibrate measurement instruments and equipment at regular intervals, and perform preventative maintenance when applicable • Develop robust measurement systems per medical device requirements, program CMM and automated vision systems, develop test methods for hand tools and gages • Review, interpret, and analyze Geometric Dimensional and Tolerance (GD&T) requirements per specifications to perform test method development and validation • Interpret specifications, drawings, customer documentation and other documents as necessary to support metrology projects • Plan, coordinate, conduct Test Method Development and Validation activities, Initiate inspection plans for new/revised product • Perform measurement system analysis (MSA) for Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution studies
• Perform statistical analysis of inspection data, process characterization, DOE results, ANOVA, Capability Analysis • Support Engineering and Supplier Quality group in identification of equipment and/or calibration providers. • Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product • Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA), • Support internal and external audits Senior Metrology Technician: • Train company personnel as needed in areas such as the use of equipment, inspection methods, statistical methods, processes, and quality system. • Serve as project team leader on small projects. Schedules project activities and meets deadlines • Provide mentorship to other Engineers and Technicians through experiences and education as opportunities arise • Develop ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement • Successfully manage multiple high-profile projects simultaneously • Drive best practices through the application of effective quality engineering principals and procedures across functions
Required: • 2 year degree in quality, manufacturing, engineering, or related equivalent experience • Regulated manufacturing industry experience Desired: • 2+ years of regulated manufacturing experience. • Quality certification(s) (e.g. ASQ CQE, CQT, CQA, etc.). • Class I, II and/or III Medical Device manufacturing experience. • Knowledge and experience with GMP/ISO Standards. Senior Metrology Technician Required: • 4 year degree in quality, manufacturing, engineering, or related Technical Field • 3+ years experience in manufacturing industry with quality experience. Desired: • Quality certification(s) (e.g. ASQ CQE, CQT, CQA, etc.). • Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820 (210/211 and ICH Q7 as applicable).
• Class I, II and/or III Medical Device manufacturing experience. • Knowledge and experience with GMP/ISO Standards.
Competencies
Ability to read, write, speak and understand the English language (with a help of a translator, if needed) • Ability to communicate clearly by conveying and receiving ideas, information and direction effectively • Ability to demonstrate adequate job knowledge to deliver a world class performance • Ability to challenge oneself to consistently meet all goals and deadlines • Willingness to strive for excellence by producing work that is free of errors and mistakes • Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately • Commitment to making improvements company wide • Demonstrated competence using Microsoft Office, Project, Access and JMP • Comprehensive understanding of applicable Work Instructions, SOP'S, and ISO standards • Working knowledge of statistical methods associated with six sigma and quality control. • Able to perform math functions • Effective project leader • Experience with lean manufacturing principles and their implementation • Good hand/eye coordination and depth perception • Good manual dexterity • Correctable normal reading distance vision