Job SummaryZimmer 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 ResponsibilitiesLead 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 CompetenceKnowledge 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 regulation
Education/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 InformationEOE 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.