Metrology Group Leader (538474)
Company: Zimmer Biomet
Location: Warsaw
Posted on: May 15, 2022
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Job Description:
Job Summary
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.
Principal Duties and Responsibilities
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.
Expected Areas of Competence
--- 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.
Education/Experience Requirements
--- 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.
Travel Requirements
Less than 5%
Additional Information
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.
EOE/M/F/Vet/Disability
Keywords: Zimmer Biomet, South Bend , Metrology Group Leader (538474), Other , Warsaw, Indiana
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