Quality Principal Engineer (679820)
Company: Zimmer Biomet
Location: Warsaw
Posted on: June 10, 2021
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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.
Responsible for gathering relevant, factual information and data in
order to solve quality related problems using the Zimmer Global
Corrective and Preventive Action (CAPA). Resolve issues by
identifying and applying solutions from acquired technical
experience and guided precedents utilizing the CAPA process. Plan
and lead CAPA teams by identifying and organizing activities into
time dependent sequencing with realistic timelines. Work
effectively/productively with all departments by developing a team
atmosphere. Anticipate problems and perform training/mentoring to
CAPA team members in support of continuous monitoring in Quality
and Manufacturing Systems. Create plan to improve systems and avoid
obstacles. Improve the proficiency of CAPA team members in the root
cause analysis and verification of effectiveness phases of CAPA.
Interacts with many different functional departments, suppliers,
and experts outside Zimmer Biomet to facilitate timely execution of
CAPA activities.Principal Duties and
Responsibilities
Lead CAPA process; including,
collecting and analyzing data to appropriately and efficiently
identify ‘Root Cause’ and ensuring ‘Verification of Effectiveness’
plans are comprehensive, to facilitate overall improvement in
performance of key quality system elements, monitor metrics for
determining the effectiveness of applicable quality systems,
develop processes and plans to address improvements as
identified.
Communicate CAPA best practices ensuring the necessary training is
developed and delivered to drive business transformation activities
and long-term adoption of Zimmer Global CAPA procedures and
applications.
Lead or function as part of special project teams to develop and
oversee consolidated mechanisms for division quality system
reporting.
Periodic review of regulatory agency requirements for application
toward global CAPA system.Expected Areas of Competence
Knowledge of statistics, process
control, and process capability.
Demonstrated ability to foster individual and group development by
identifying and arranging formal training on CAPA best practices
including: problem definition, investigation, identification of
root cause, implementation plan development and verification of
effectiveness.
Demonstrated knowledge of and experience in medical device quality
assurance and systems.
Demonstrated knowledge of Lean Manufacturing and Six Sigma
Principles.
Demonstrated willingness to act in a balanced and ethical manner
when dealing in gray areas of regulationEducation/Experience
Requirements
??B.S. in engineering or an
alternative Bachelor’s degree program with certification as a
quality engineer (e.g. CQE) or the Reliability Engineer
Certification (CRE) granted through the American Society of Quality
(ASQ)
??6+ years’ of total engineering experience
??4+ years’ experience in Engineering focused in one of the
following areas, Quality, Quality Assurance, Manufacturing,
Development, Regulatory or Compliance
??4+ years’ FDA regulated industry experience preferred.
??Combination of education and experience may be considered (in
evaluating experience relative to requirements)Travel Requirements
??Up to 20%Additional Information
EOE M/W/Vet/Disability
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.
Keywords: Zimmer Biomet, South Bend , Quality Principal Engineer (679820), Other , Warsaw, Indiana
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