11 days old

Director, Quality Operations

Johnson & Johnson
Warsaw, IN

DePuy Synthes Companies of Johnson & Johnson is seeking a Director, Quality Operations to be located in Warsaw, IN.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of our company, we are an organization with a focus on activating insights to develop innovative and comprehensive solutions to inspire advances in patient care.

The Director of Quality Operations is part of the site senior leadership team and is responsible for ensuring appropriate quality assurance expertise and guidance for the operations in line with company and regulatory guidelines. This role is a key leadership role and is critical in ensuring the skills and competencies are consistent with the business needs, developing a strong Quality talent pipeline, verifying that Quality Systems are in place to maintain the required compliance level across the manufacturing site and partnering with all functions to ensure reliable process execution. The role collaborates with both the primary manufacturing site and other sites in the network to manage an end to end supply chain, J&J Corporate Bodies, Notified Bodies, Worldwide Health Agencies, strategic partners and suppliers.

*\tParticipates as a key member of the facility management team for Warsaw plant and Joint Reconstruction Supply Chain Quality Leadership Team.
*\tRecruitment, coaching and development of QA personnel, consisting of a team of approximately 45 Quality professionals, to ensure a strong talent pipeline for the site as well as the wider JnJ community.
*\tWork closely with Operations in a team-based environment to ensure process and product compliance with all relevant quality standards.
*\tEnsure new products are transferred into routine production effectively with all development documentation completed.
*\tProvide quality oversight for the disposition of incoming materials, in process material and manufactured final product versus product standards/specifications, the monitoring of environmental conditions, the validation of all design, manufacturing prior to sterilization (as applicable), and the timely management reporting of internal/external quality results with conclusions for all required corrective actions
*\tEnsure that all Health & Safety requirements are fulfilled in accordance with the responsibilities defined in the Company Safety Statement, as well as actively promote Health & Safety within the department and ensuring it's a priority for all direct reports.
*\tEnsure audits are conducted in accordance with requirements of ISO 13485, FDA QSR 21 CFR Part 820 or other recognized regulatory standards for all markets in which our products are sold.
*\tBe the Management Representative for DePuy Synthes, Warsaw Facility
*\tDevelop and implement a Strategic Continuous Improvement programs for Warsaw site quality business unit
*\tChampions the creation and maintenance of Credo based environment in his/her area of responsibility, living Credo values, building trust and caring for people.

*\tA minimum of a Bachelor Degree is required, preferably in Engineering or Science Discipline.
*\t10+ years of experience in a GMP and/or ISO regulated industry is required.
*\tMedical device industry experience is preferred.
*\t5+ years of direct people management experience is required.
*\tStrong business insight, interpersonal and performance management skills for a highly global matrix organization and teams with diverse cultures and business practices is required.
*\tAbility to interact with, influence, and lead cross-functional, cross-business unit teams is required.
*\tStrong tactical planning and execution abilities, including strong organization skills is required.
*\tExperience taking initiative with innovative ways to problem solve in a fast-paced, changing business environment is required.
*\tProcess Excellence and Lean experience desired.
*\tThis position will be based in Warsaw, IN and will require up to 10% travel.

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply for this opportunity today.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-Indiana-Warsaw-
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID
Posted: 2019-01-04 Expires: 2019-02-13

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Director, Quality Operations

Johnson & Johnson
Warsaw, IN

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