Responsible for directing the quality assurance processes at Zimmer manufacturing sites. Utilizes quality statistics to develop effective strategies to improve the performance of the quality system.
Develops relationships with key development and manufacturing clients to identify emerging needs. Resolves complex problems that have implications beyond own area. Requires professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all Warsaw company disciplines and business units. Takes accountability, achieves results and develops self and others
Principal Duties and Responsibilities
Provides leadership and guidance to Quality, Manufacturing, Development, Research and Sourcing departments. Establishes requirements and assures product conformance through appropriate inspection and test activities.
Develops and implements quality planning, inspection methods and defect prevention/corrective action processes for new and existing products.
Develops and implements quality strategy and objectives.
Identifies and solves product and process problems and supports various operational groups.
Prepares and monitors operating and capital budgets.
Responsible for development and oversight of departmental goals and projects.
Directs and oversees the work of quality professionals supporting manufacturing and design assurance.
Fosters employee development to prepare others to assume increased levels of responsibility.
Expected Areas of Competence
Requires extensive independent decision making ability and applying regulations and standards (ISO, QSR, etc.) governing the manufacturing and distribution of medical devices.
Demonstrated management ability including effective employee selection, development, motivation and performance.
Demonstrated ability to achieve productivity goals without sacrificing quality in a manufacturing environment.
Understand interactions and interdependency of elements within the quality system in a medical device manufacturing organization.
Full working knowledge and experience with all development procedures and processes, including design control and FOCUS process.
Must be able to work with all levels of employees, including hourly production employees through senior management.
Must have a thorough knowledge of ISO, QSR and other relevant FDA requirements as applied to medical device development, manufacturing and quality.
Must possess excellent written and oral communication skills and the demonstrated ability to communicate with individuals of varying backgrounds.
This position requires a Bachelor's Degree preferably in engineering or a related discipline with 7+ years of work experience in quality functions
Quality discipline certification preferred (e.g., CQA, CQE, CQM, etc.).
Must be experienced in all aspects of modern quality control methods such as nondestructive testing, metrology, statistical process control, quality cost accounting, applied statistics and inspection.
Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.
Quality Engineering Certification (ASQ) a plus
Up to 10%