Quality Sr Engineer

Zimmer Biomet Job Description

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.

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/productively with all departments by developing a team atmosphere. 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 Zimmer to implement Zimmer Quality goals.

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. Define the test method validation requirements for material testing. 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 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. Define the test method validation requirements for material testing. 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 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 frontroom 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 re-qualify supplier processes.

Develop…