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Quality Engineer III

4 months ago

Palm Beach Gardens, United States ZimVie Full time

We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients’ smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie — we hope you’ll consider being a part of it


Job Summary:

Works on problems of diverse scope where analysis of information requires evaluation of identifiable factors. Devises solutions based on limited information and precedent and adapts existing approaches to resolve issues. Uses evaluation, judgement, and interpretation to select right course of action. Complete knowledge and full understanding of area of specialization, principles, and practices within a professional discipline. Assess unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify causes. Resolves and assesses a wide range of issues in creative ways and suggests variations in approach. 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 ZimVie to implement ZimVie Quality goals.

Principal Duties and Responsibilities:

  • Utilize Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
  • Lead Material Review Board (MRB) and Nonconformance Report (NCR) process related to Quality issues (E.g., Calibration Out of tolerance, QC inspection failures, etc.). Understand and use Root Cause Analysis tools to solve Quality issues. Review / approve nonconformance investigations.
  • Perform Gage R&Rs related to inspection methods. Propose new/alternate inspection methods to improved Quality, inspection time, etc.
  • Perform Installation Qualification (IQ) related to inspection equipment. Review Operational and Performance Qualification protocol and reports (OQ/PQ).
  • Generate Quality monthly KPI metrics and report to management.
  • Perform procedure updates as required. Submit Document Change Requests related to process improvements and/or Procedure Periodic Reviews.
  • Lead efforts for continuous quality and customer satisfaction improvement opportunities. Lead and perform CAPA investigations.
  • Work with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities and lifecycle management.
  • Write review and/or approve process and product validation protocols and reports, equipment qualification, engineering change orders, Test Method Validations (TMV) and software validations.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.
  • Technical problem solving, failure analysis, and root cause determination.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
  • Assigns/review quality inspection testing and test data. Keeps department supervisor abreast of activities and issues of the quality group.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures (FDA Part 820, ISO-13485, Part 11, etc.)
  • Perform other duties assigned as needed

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 (i.e., knowledge, skills, and abilities)

Required

  • • A minimum of 5 years of quality, design quality, complaints, Supplier Quality and/or manufacturing engineering experience in a medical device, pharmaceutical, and/or biopharma industry.
  • Ability to define problems, collect data and analyze data, establish facts, and draw conclusions and recommendations.
  • Strong knowledge in understanding blueprint/drawing/ and/or GD&T.
  • 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.
  • Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, PFMEA, and product testing methods.
  • Knowledge of statistics, process control, and process capability.
  • Requires ability to work in office at least 4 days a week.

Preferred

  • CQE and/or Green belt certification
  • Experience with Minitab software
  • Six sigma and/or knowledge of Process Excellence tools

Education/Experience Requirements

  • B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) is preferred but not required.
  • 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.
  • Minimum 4+ years’ experience in a Quality Engineering role, or an equivalent combination of education and experience.
  • Combination of education and experience may be considered (in evaluating experience relative to requirements)


Travel Requirements

Up to 5%


ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.

ZimVie generally does not sponsor applicant work visas for this position.