Zimmer Biomet is a world leader in musculoskeletal health solutions. 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.
The Quality Engineering Manager is responsible for managing Design Controls and Risk Management processes and systems to ensure the effective implementation of a Quality Management System that complies with the applicable quality systems standards and regulations. The Manager will ensure existing design quality processes deliver high quality products the first time. In addition, appropriate metrics shall be implemented to ensure products meet the regulations and product requirements. The incumbent interacts with various functions and stakeholders (internal or external) to accomplish compliance and product conformance to the Zimmer Biomet/NewCo Quality Policy and Objectives, and business goals. The incumbent manages and directs a group of quality professionals/engineers dedicated to the implementation and support of Design Controls and Risk Management. And directs Quality Engineers participating on New Product Introduction (NPI) and Sustaining projects. Responsible for managing and maintaining an operating budget.
Principal Duties and Responsibilities
Manages, implements and maintain quality system processes in compliance with the applicable standards and regulations.
Provides leadership to team on new product development projects to ensure quality is designed into the product the first time.
And the identification and implementation of improvements for quality systems processes.
Actively monitors data sources and collects data to report to Top Management on quality design process/systems performance and to identify improvement opportunities.
Develops and implements processes, procedures and instructions to maintain the effectiveness of the Design Controls and Risk Management or to improve it when necessary.
Participate and support external audits (corporate or regulatory agencies) audits. Correspond with these agencies regarding compliance issues, as needed.
Hire, train, develop, and manage quality engineer personnel to effectively support and continuously improve the Quality Management System.
Maintains departmental budget within prescribed limits.
Expected Areas of Competence
Ability to work within a team environment and build relationships outside of the department as well as outside the company.
Proven ability to direct, build, develop and manage a team of professionals.
Must be familiar with all aspects and elements of a quality system including but not limited to Design Controls, Risk Management, CAPA, root cause analysis, product realization and measurement, analysis and improvement processes.
Ability to deal with difficult situations with tact, professionalism, and discretion.
Demonstrated technical expertise is preferred in the following arenas: design and development, risk management, product verification and validation, test method validation, usability engineering.
Ability to work with minimum supervision and consider options to complete quality work.
Excellent communication and presentation skills (both oral and written), and ability to work with employees at all levels of the organization.
Proficient in personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.
B.S. in engineering or an alternative Bachelor’s degree in a related discipline plus a minimum 6-8 years’ experience in quality compliance/quality systems.
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.