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