What are the responsibilities and job description for the Metrology Technician position at Trelleborg Medical Solutions?
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
- 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:
Required:
- 2 year degree in quality, manufacturing, engineering, or related equivalent experience
- Regulated manufacturing industry experience
- 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.
Required:
- 4 year degree in quality, manufacturing, engineering, or related Technical Field
- 3 years experience in manufacturing industry with quality experience.
- 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
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
