Medical Devices, part of the Johnson & Johnson family of companies, is currently recruiting for a Senior Director, Quality Strategic Programs to be located in Somerville- NJ, Cornelia/ Athens- GA, El Paso- TX, San Angelo- TX, Irving- TX, Cincinnati- OH, Irvine- CA, Warsaw- Indiana, Raynham- Massachusetts, West Chester- PA, Jacksonville- Florida, Neuchatel- Switzerland, Cork- Ireland, Limerick- Ireland or Norderstedt, Germany.
Medical Devices Quality & Compliance, supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, biosurgicals, sutures, orthopedic implants & instruments and specialty surgery.
The Sr. Director, Quality Strategic Programs will be the key business partner to deliver operational excellence in quality & compliance strategies for the ISO 13465/EU MDR Program across One MD. They will drive the process of assuring the functional program for Quality & Compliance for the ISO 13465/EU MDR is established and aligned with Enterprise Quality & Compliance and the EU MDR Program Management Office ensuring tactics and measures are reflected to demonstrate timely program implementation. They will assure a robust management program is established for One MD Quality and Compliance with respect to EU MDR and integrated into the overall Depuy Synthes, ETH-CSS QRC organizations, Supply Chain and MD organization where applicable.
The Sr. Director, Quality Strategy, will be an active member of the One MD EU MDR Program Management Team, have responsibility for:
• Roll-out of the QMS Implementation Plan in 2017
• Work with
• Help design of PMS gaps and implementation Plan for 2018/2019
• Understand MDR regulations and timelines with help of JNJ JJRC and Regulatory Affairs to become the SME for EU MDR
• Accountable for $17 million 2017 budget. The current 2017 budget is $50 million for the project and $15-17 million for the QMS/PMS portion (or ~34% of the total).
• Manage and coach 2 -3 Program managers internal to support roll out plans for all Ethicon/CSS and DePuy Synthes business units
• Manage Ernst and Young and Your Encore resources (3) as well as other external resources, as required
• Relationships with Notified Bodies through JNJ Regulatory
• Run Governance with Steering Committee
• Communications to JNJ leadership and internal audiences
• Initial coordination of EU MDR Training and certification for JJRC auditors
• Responsible to knowledge transfer to Pharma, Consumer and Consumer Med Tech via extended core team meetings.
The Sr. Director, Quality reports to the Vice President, Quality Strategy, PMO & Network ETH-CSS.Qualifications
• Bachelor’s degree in engineering, business, and science or quality, regulatory & compliance disciplines is required. Graduate degree/studies in science, business, engineering, finance or organizational management or equivalent experience preferred.
• A minimum of 10 years of experience in positions of increasing responsibility supporting large, multi-site, global organizations is required.
• This strategic role requires a diverse business background, with direct experience in medical devices and diagnostics, with specific QRC competencies inclusive of product and process innovation, planning, manufacturing, quality systems and compliance.
• Experience with the global demands of the role specifically: multi-cultural / multi country locations and healthcare regulatory requirement is preferred. Leadership experience in line functions (R&D, Supply Chain or Commercial) would be an asset.
• Strategy Development and Project management across the organization, with measurable, financial, quality and compliance results is required; proven experience with strategy development and project management across the organization, were measurable, financial, quality and compliance results were required; understanding the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer is required; the ability to build consensus and impacts outcome without always having line authority and is able to negotiate trade off decisions across the organization is required
• The candidate should have strong executive presentation skills; Creating a direct and indirect organization that delivers results; Creating a future vision and gaining support and alignment to that vision; Developing working strategic plans in alignment with the corporate strategic goals; Attracting and developing superior talent; Collaborative approach; Organized and able to manage complexity; Strong analytical and strategic skills with a Bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high level and detailed.
• The ability to travel up to 30% is required domestic and internal depending on location.
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J2W: LI NAPrimary Location
United States-New Jersey-SomervilleOther Locations
Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel, North America-United States-Texas-Irving, Europe/Middle East/Africa-Ireland-Limerick-Limerick, North America-United States-Pennsylvania-West Chester, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-Georgia-Cornelia, North America-United States-Georgia-Athens, Europe/Middle East/Africa-Germany-Schleswig Holstein-Norderstedt, North America-United States-Florida-Jacksonville, North America-United States-Texas-El Paso, North America-United States-Massachusetts-Raynham, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-California-IrvineOrganization
Ethicon Inc. (6045)Job Function
Quality (Generalist)Requisition ID
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