Shannon, Munster, Ireland
18 hours ago
Quality & Regulatory Compliance Senior Director

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 recognized.


What You Can Expect

 

Responsible for implementing and overseeing processes and systems for key quality system elements to leverage among our sites in Ireland (Shannon & Galway) & Berlin.Utilizes appropriate tools to develop effective strategies to improve the performance of the quality system.Develops relationships with key stakeholders 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 company disciplines and business units.How You'll Create Impact

 

Develops and implements quality system strategies and objectives for area of responsibility.Provides leadership and guidance to Quality, Manufacturing, Development, Research, Sourcing, and IT departments as appropriate to the role.Develops metrics for determining effectiveness of applicable quality systems and develops plans to address improvements as identified.Identifies quality system issues and improvements and works with various operational groups to create plans to resolve and implement.Evaluates the effectiveness, value, and weaknesses of quality systems at other locations and makes strategic recommendations aimed at harmonizing systems and resolving systemic issues.Prepares and monitors operating and capital budgets.Develops and prioritizes departmental objectives according to company-wide objectives. Responsible for the oversight of goal achievement and project completion.Directs and oversees the work of quality professionals and technical staff supporting quality system development, implementation, and administration.Fosters employee development and engagement to prepare others to assume increased levels of responsibilityDevelops vision and strategic priorities for Quality and works with all stakeholders to ensure aligned execution.In collaboration with the EMEA Quality Leadership team, works to drive standardization and best practice across the EMEA region.What Makes You Stand Out

 

Requires independent decision-making ability and the ability to interpret and apply regulations and standards (ISO, QSR, etc.) as appropriate.Demonstrated leadership ability including effective employee selection, development, and motivation along with performance management.Requires the ability to analyze quality system projects and develop project plans to achieve successful implementation of systems.Must be knowledgeable and stay current in the regulatory requirements for key quality system elements, in order to maintain compliance.Understand interactions and interdependency of elements within the quality systemDemonstrated ability to learn key orthopedic product and process knowledge quickly.Must be able to balance priorities among many ongoing tasks, and be responsive to critical situations,Must have excellent written and oral communication skills and exhibit organized work habits and the ability to be detail oriented when required.Must be able to work with all levels of employees, including hourly production employees through senior management.Must possess excellent written and oral communication skills and the demonstrated ability to communicate with individuals of varying backgrounds. Familiarity with orthopedic hip and knee product lines is preferred.Must be able to work across functions and geographies and develop a strong network of contactsYour Background

 

B.S. degree in engineering, science, management or other pertinent area is required. An advanced degree in a technical area is preferred but not essential if sufficient work experience can be shown.Technical knowledge with ten to twelve years of experience in the medical device industry. Interpretation of FDA (and other major international regulatory body) regulations as they apply to Zimmer and other appropriate areas of the company. Prior cross functional experience in a development and/or manufacturing environment preferred.Travel Expectations Up to 20%

EOE/M/F/Vet/Disability

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