Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
The Metrology Leader with the direction from the QA Supervisor and Quality Management perform precise and accurate measurements on mechanical equipment throughout the company. The group leader also provides necessary calibration reports to the Supervisor or Manager and departments requiring appropriate calibration paperwork. Assist in resolving problems that prevent completion of calibrations.
Read and understands technical procedures, standards and engineering drawings and inter-department correspondence, reports, and documentation. Complies with all GMPs, ZWIs, etc. Maintain a neat, organized and orderly calibration laboratory and an accurate filing system (of calibration records). Completes calibration QIRs and CAPAs in a timely manner. Supports any 3rd party or competent authority (FDA, etc.) audits. Works with customers to optimize gage designs. Review monthly trends for out of tolerance gages and addresses unfavorable trends by putting in place proper corrections. Work closely with Engineers to determine process/inspection requirements as pertains to the IM&TE. Assist with any specialized training needs; assist staff in identifying all other training needs; accreditation requirements, purpose, scope, administration, and practice within the metrology department and also within QA. Perform training for Calibration Technicians concerning calibration, department policies and procedures. Reviews current publications for staying up to date with trends, practices, and procedures available to the technician. Develop, and facilitate continuous improvement efforts within the department and companywide. Provides guidance in assessing measurement process variability and uncertainty. Researches / acquires new measurement standards and technologies as required. Work closely with Engineers to determine process/inspection requirements as pertains to the IM&TE Performs miscellaneous job-related duties as assigned by the Supervisor/Manager. Perform calibration audits as time permits, or as work order/back log and priorities dictate. Special Projects: Perform special projects as assigned by Quality Management.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the \"essential functions\" for purposes of the ADA.
* Candidates must be flexible and have excellent oral and written communication skills. * A background in production and quality is also an essential part of the position. * Demonstrate ownership for the integrity of the work. * Handle assignments of any complexity but must know when to ask for help. * Candidates should have experience in new product development and/or manufacturing process development for new product rollouts. * Candidates may train on all shifts. * Capable of calibrating custom gages on a CMM. * Goes beyond existing knowledge base and expands Zimmer's understanding, methods, and procedures leaving a base for others to utilize and build upon. Challenges current methods / strives for improvement. * Highly competent in mathematics (geometry, trigonometry, algebra). Ability to use and calibrate nearly all IM&TE within Metrology (micrometer, caliper, optical comparator, thread gages, go/no go gages, contour tracer, profilometer, electronic height gages and custom gages) and test instruments (pull and torque testers). Experience with Pressure Gages, Mass Flow Controllers and programmable inspection machines (vision systems, CMM, etc.) a plus. * Ability to read standard operating procedures and engineering drawings; basic understanding of engineering drawings using Geometric Dimension and Tolerancing (GD&T) required.
* Prefer a degree in industrial, mechanical, bio-medical engineering, other engineering science, or combination of education/experience. Experience in a QA/QC or machine shop environment preferred. High School Diploma or GED required. * Must have 5 years of metrology experience in physical and electrical disciplines, preferably in a medical device manufacturing operation. * Thorough knowledge of FDA / ISO standards relating to test and measurement requirements. These include, but are not limited to GMP, ISO 17025 and ISO 13485. * Knowledge of statistical tools used to evaluate measurement variability and uncertainty. These include GR&R, DOM, use of PPAP and FAL. * Have proven problem solving skills, and the ability to effectively manage multiple projects. * TMDE (Time Measurement and Diagnostic Equipment) training helpful. * PMEL (Precision Measurement Equipment Laboratory) training helpful. * Familiarity with ANSI/NCSL Z540-01 and ISO/IEC17025 a plus.
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At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
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