Metrology Technician - Quality

Trelleborg•Delano, MN

16d

About The Position

Tasks and Responsibilities 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 Education and Experience 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. 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 #TMS

Requirements

2 year degree in quality, manufacturing, engineering, or related equivalent experience
Regulated manufacturing industry experience
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

Nice To Haves

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.

Responsibilities

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