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Quality Principal Engineer I
Quality Principal Engineer IZimmer Biomet • Warsaw, IN, US
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Quality Principal Engineer I

Quality Principal Engineer I

Zimmer Biomet • Warsaw, IN, US
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At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

Job Summary

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively / productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals. Mentors less senior staff within the department.

Principal Duties And Responsibilities

  • Evaluating process methods and equipment to meet performance and quality requirements.
  • Establishing quality plans for equipment and processes for general and specific product performance needs
  • Monitoring performance of processes to a standards
  • Applying ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
  • Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
  • Developing and maintaining department and project budgets
  • Training and mentoring less experienced Engineers and cross-functional peers
  • Identifying and / or developing new technologies

Expected Areas Of Competence (i.e., Knowledge, Skills And Abilities)

  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
  • Facilitates team efforts on quality engineering projects.
  • Ability to deliver, meet deadlines and have results orientation.
  • Able to communicate both orally and in written form to multiple levels of the company.
  • Understanding of QSR / ISO regulations, design assurance and FMEA.
  • Knowledge of statistics, process control, and process capability
  • Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
  • Thorough knowledge base of existing Zimmer Biomet products and a basic understanding of competitive products
  • 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)
  • 7 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.
  • Travel Expectations : Up to 20%

    Physical Requirements : EOE / M / F / Vet / Disability

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