Director, Quality Systems Job

Job description

Director, Quality Systems-7015150513DescriptionETHICON, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Director, Quality Systems to be located in Somerville, New Jersey.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.
The Director, Quality Systems is a critical leadership position within the ETHICON business accountable for the effective establishment, maintenance, and continuous improvement of the ETHICON quality systems enable the design, manufacture, delivery, and lifecycle management of quality products to ETHICON customers. This leader implements Quality Systems strategy, and leads the translation of the strategies into effective and robust quality system procedures, technologies and business practices to enable the realization of J&J and ETHICON Quality Policy, quality objectives, and business strategies. The Director, Quality Systems will continuously measure and analyze the quality management system and supporting technology in order to identify opportunities for improvement as well as to continuously review the external environment and defined requirements necessary to meet the changing regulatory and business needs.
The Director Quality Systems will set governance to implement the quality system strategy and standards for the ETHICON business across all Ethicon locations globally. They will maintain and continuously improve quality systems, including quality manual, Management Review, Configuration Management, Change Control, Records Management, and associated technologies and procedures that support the development, manufacture and delivery of high-quality products in order to meet J&J and external regulatory requirements, as well as customer expectations. The Director will establish business practices to support the recording, evaluating, and reporting on quality and reliability are met, directing the evaluation of data and metrics reports for inclusion in management reports, and site and franchise management reviews; partner with the IT organization to identify, develop, validate and deploy innovative technology solutions and applications to deliver quality systems across the business; create the business cases and value propositions for programs and manage capital appropriation requests and project budgets. This role will provide quality system subject matter expertise to the business into the execution of related initiatives and external regulatory audit support as well as standardize Ethicon quality systems practices and procedures, and leverage J&J compliance policies, metrics and resources across the enterprise. They will lead the quality system talent development strategy focused on enhancing leadership and quality system capabilities across the Ethicon business and provide leadership and development to all reports assuring active participation in the performance management, succession planning and talent development activities. They will have worldwide responsibility across the ETHICON operating companies and platforms.
QualificationsA minimum of a BA or BS is required. An advance degree is preferred. Green Belt or Black Belt Certification is preferred. Experience in medical devices , biologics or pharmaceutical industry is required. Experience developing a high performing team in Quality Systems or related subject matter is required. A minimum of 10 years of overall business experience is required. A minimum of 5 years of direct experience with all aspects of Quality Systems in an international, global context, in a regulated healthcare environment is required. Strong analytical and strategic skills with the ability to zoom-in/zoom-out for strategic and tactical, high-level and detailed approach is required. Must have a proven track record of leading and executing remediation of issues and managing complexity and ambiguity as well as experience leading risk-based programs is required. Change management including recognizing and building support for change and Project management experience is required. Developing working strategic plans in alignment with enterprise strategic goals is preferred. The ability to collaborate and partner across all levels of the organization as well as influence and build consensus without having line of authority is required. Business acumen, executive presence and strong presentation skills are preferred. Outstanding communication skills, with the ability to inspire trust and quickly build credibility within multiple functions, and organizational levels is preferred. A proven track record of engaging organization and demonstrating collaboration across the organization and at all levels is required. Having a balanced technical understanding of quality systems, products & processes combined with superior business and compliance acumen is preferred. The ability to present a vision and lead a team around the vision is required. Demonstrating Credo-Based decisions on a daily basis is required. Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally is preferred. Keeping the customer central to all thinking is required. The ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures is preferred.
This position will be located in Somerville, NJ and have up to 25% of both international and domestic travel.
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J2W: LI NAPrimary Location:North America-United States-New Jersey-SomervilleOrganization: Ethicon Inc. (6045)Job Function: Quality SystemsCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement