Quality Principal Engineer - Packaging Engineering (443633)

Company Name:
##### 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 to implement Zimmer Quality goals.
##### 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
##### Expected Areas of Competence
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 products and a basic understanding of competitive products
##### Education/Experience Requirements
B.S. in engineering or an alternative Bachelor's degree program
Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred but not required
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 required.
Packaging Engineering experience in medical devices is required , and sterile packaging experience is required .
Combination of education and experience may be considered. Minimum of a Bachelor''s degree.
##### Travel Requirements
Up to 20%
Requisition Number: AMER01479
Employment Type: Full-time
Location: Warsaw

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