Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
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. - 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 re-qualify 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.
• Requires a bachelor’s degree in Engineering or related field. Must have 5 years of experience in a Quality or Manufacturing Engineering role or related position.
- 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.