Senior Quality Engineer I

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At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

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

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

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

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Warsaw, IN $85,000.00-$90,000.00 1 day ago

Warsaw, IN $80,000.00-$95,000.00 1 day ago

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