ZimVie

Quality Engineer III

ZimVie

full-time

Posted on:

Location Type: Office

Location: Palm Beach Gardens • Florida • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • 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.
  • 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

Requirements

  • 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.
Benefits
  • ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality EngineeringRoot Cause AnalysisStatistical Process ControlDesign of ExperimentsFailure AnalysisProcess CapabilityGage R&RInstallation QualificationOperational QualificationPerformance Qualification
Soft skills
Analytical SkillsProblem-SolvingTeam CollaborationCommunication SkillsResults OrientationJudgmentAdaptabilityCreativityLeadershipRelationship Building
Certifications
ISO-13485FDA Part 820Six Sigma