Quality Engineer II (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 moderate scope which are often varied and routine where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Applies learned techniques and contributes to analysis and investigation to solve problems. Develops professional expertise, applies company policies and procedures to resolve a variety of issues. Determines a course of action based on guidelines and modifies processes and methods as required. Builds productive internal/external working relationships to resolve mutual problems by collaborating on procedures or transactions. Focuses on providing standard professional advice and creating initial reports/analyzes for review by experienced team professionals. 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.
• Basic understanding of product drawing and specifications.
• 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
• 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 ro