Overview
Senior Quality Engineer- Risk Management at Zimmer Biomet. Join to apply for the Senior Quality Engineer- Risk Management role at Zimmer Biomet. Zimmer Biomet is a global medical technology leader with a long-standing commitment to mobility and patient care.
As a Zimmer Biomet team member, you will contribute to developing, implementing, and maintaining risk management systems and processes to ensure regulatory and quality compliance, and you will lead site investigations into issues. You will conduct risk assessments, identify potential risks in products and processes, and collaborate with cross-functional teams to implement corrective actions and preventive measures. You will help ensure products conform to established requirements and standards through audits, inspections, and testing activities, interfacing with various functional departments, suppliers, and external experts to achieve Quality goals.
Responsibilities
* Develop and implement processes, procedures and instructions to sustain and improve the Quality Management System.
* Develop and maintain risk management systems, perform risk assessments on processes and equipment to identify potential hazards.
* Support Top Management in the development and implementation of quality systems strategies and objectives.
* Identify and solve product and process problems.
* Support various operational/manufacturing groups and suppliers in resolving and preventing quality issues.
* Perform quality engineering analysis and responses for corrective and preventive actions.
* Coordinate with suppliers, manufacturing, engineering and other functional areas to verify implementation and effectiveness of corrective/preventive actions for non-conformances.
* Conduct audits and assessments of internal processes and supplier manufacturing sites.
* Develop validation strategies and support successful execution of validation activities.
* Support and represent the site during external regulatory audits.
Qualifications / What Makes You Stand Out
* Familiarity with all aspects of a quality system including management responsibility, resource management, product realization and measurement, analysis and improvement processes.
* Knowledge of quality assurance techniques such as inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control.
* Demonstrated technical expertise and ownership for the integrity of work.
* Ability to work independently or as part of a team and consider options for completing work.
* Strong written and verbal communication skills.
* Experience in a regulated industry, preferably medical devices.
Your Background
* Bachelor’s Degree in Quality or Engineering or an equivalent combination of education and experience.
* Must be familiar with Microsoft Office Suite.
* Minimum of 5 years of experience in Quality Engineering.
* Experience working in a regulated industry, preferably medical devices.
EOE/M/F/Vet/Disability
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