Quality Operations Engineer III

2 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


Principal Duties and Responsibilities:

  • Creating, maintaining, and improving controlled technical documents such as prints, procedures, bill of materials and routers.
  • Conducting feasibility study on advanced processes to estimate product cost and analyze capital equipment, capacity, and capability requirements.
  • Establishing and improving process methods which meet performance and quality requirements.
  • Leading quality and manufacturing equipment qualification and process validation project(s)
  • Solving a variety of complex product, quality, and/or process performance issues
  • Developing rationale to set new process performance and quality standards.
  • 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.
  • Perform Gage R&Rs related to inspection methods. Propose new/alternate inspection methods to improved Quality, inspection time, etc.
  • Perform procedure updates and submit Document Change Requests related to process improvements and/or Procedure Periodic Reviews.
  • 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.


Expected Areas of Competence (i.e., knowledge, skills, and abilities):

  • Extensive knowledge of mechanisms required to implement processes and manage product flow.
  • Full working knowledge of the development process and procedures.
  • Ability to lead and prioritize medium complexity project assignments and complete work in a timely manner.
  • Ability to define problems, collect data and analyze data, establish facts, and draw conclusions and recommendations.
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
  • Knowledge of statistics, process control, and process capability.


Education/Experience Requirements:

  • B.S. in mechanical, industrial, or other engineering science, or alternative bachelor’s degree program with certification as a quality engineer (e.g. CQE) is preferred
  • Minimum of 5-8 years of manufacturing engineering experience
  • Knowledge in Lean Principles and or Six Sigma or other problem-solving methodology is preferred.


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.

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