Quality Engineer III (On-site)

 

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 t