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Senior Quality Engineer I - Now Hiring!

Senior Quality Engineer I - Now Hiring!

Zimmer BiometWarsaw, IN, United States
30+ days ago
Job type
  • Full-time
Job description

Valued Team member : We are glad you are exploring new opportunities within Zimmer Biomet!

What You Can Expect

How You'll Create Impact

  • Provides leadership for quality engineering projects on design implementation, testing, documentation, support, and maintenance.

Lead projects impacting supplier processes by applying structured methodology to project management.

  • Evaluate process by conducting capability study.
  • Perform inspection method verification and source inspection of product, as required.
  • Evaluate process risk documentations and control documents for acceptance of product and process.
  • Review and disposition master validation plans, verification and validation protocols
  • Initiate and manage changes in the Change Management System.
  • Formulates procedures, specifications, requirements and standards for acceptance of Zimmer products and processes.

    • Define requirements for internal and external changes impacting supplier processes.

  • Identify the requirements for contact materials used by component and subcomponent suppliers.
  • Define methodology for process verification and validation.
  • Establish specifications for first article acceptance.
  • Develops and implements corrective / preventative action plans

    • Perform product and process containment to reduce the risk and impact of the nonconformance.

  • Utilize root cause analysis tools (e.g. 5 Why, Ishiwaka).
  • Develop corrective / preventive actions to address root causes.
  • Use statistical sampling methods to confirm effectiveness.
  • Collects and analyzes data for gauge and product evaluation.

    • Perform measurement system analysis (gage R & R).

  • Utilize statistical Process Control techniques to evaluate and control processes.
  • Gather data from ERP system (XA, JDE) to use for evaluation.
  • Provides technical support during audits.

    • Support front room and backroom by producing supporting documents.

  • Work with the audit response team in implementing corrective actions and verifying effectiveness.
  • Lead onsite and desktop audits to qualify and requalify supplier processes.

    • Develop and execute audit plans to verify compliance to standards and regulations.

  • Issue corrective actions and follow up on effectiveness.
  • Prepare technical audit reports.
  • Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer.

    • Evaluate and disposition nonconformances conditions per medical device industry regulations and quality control procedures.

  • Function as a liaison between supplier and internal teams to ensure product quality.

    • What Makes You Stand Out

  • Must have 5 years of quality engineering experience or related.
  • Must have 3 years of experience required in a Quality or Manufacturing Engineering role, or an equivalent combination of education and experience.
  • Must have 3 years of experience applying corrective and preventive actions (CAPA / SCAR), product / process containment activities, root cause analysis, problem solving and risk management techniques to minimize quality risks.
  • Must have 3 years of experience in nonconformance Evaluation and disposition nonconformance's per industry regulations and quality control procedures.
  • Must have 3 years of experience using verification and validation concepts; such as IQ / OQ / PQ in manufacturing and evaluating processes by conducting capability study.
  • Must have 3 years of experience Formulating procedures, specifications, requirements and standards for acceptance of products and processes.
  • Must have 3 years of experience to deliver, meet deadlines and have results orientation, ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
  • Must have 3 years of experience utilizing Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, FMEA.
  • Must have 3 years of experience with Control procedures, such as Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventative Action (CAPA) and Work Instructions;
  • Must have 3 years of experience in ability to work within a team environment and build relationships outside of the department as well as outside the company. Function as a liaison between supplier and internal teams to ensure product quality.
  • Must have 2 years of experience utilizing knowledge of measurement system analysis (gage R&R), statistical process control techniques to evaluate and control processes.
  • Must have 2 years of experience using Inspection methods for product verification, source inspection of product, and use of statistical sampling methods to confirm effectiveness.
  • Must have 1 year of experience in leading projects impacting supplier processes by applying structured methodology to project management.
  • Must have 1 year of experience in conducting SPPA / PPAP, define requirements for internal / external changes impacting supplier processes and establish specifications for first article acceptance.
  • Must have 1 year of experience Reviewing and disposition master validation plans, verification and validation protocols.

    • Your Background

    Requires a bachelor's degree in Engineering or related field, or foreign equivalent.

    Travel Expectations

    40 hours per week, Monday through Friday, 8 : 30 AM to 5 : 00 PM

    Zimmer US, Inc., 56 E Bell Drive, Warsaw, IN 46582

    EOE / M / F / Vet / Disability

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    Senior Quality Engineer • Warsaw, IN, United States