HireDiversity

West Chester, PA, US

Senior Director, Quality Regulatory Compliance -Trauma-7032121009

Description

DePuy Synthes is looking for a Senior Director, QRC Trauma located in West Chester, PA.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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 two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

Synthes Trauma offers a broad portfolio of orthopaedic fracture fixation products, including screws, plates, nails and other implants used to fix broken bones.

The Senior Director, QRC Trauma will be accountable for the development, execution and delivery of quality strategies for New Product Development (NPD) that is aligned with Trauma's business strategies. This individual will be asked to lead change initiatives associated with integration activities. He/she will partner with R&D, Operations, Regulatory & Marketing to assure all NPD quality deliverables are met within cost, quality and schedule targets. The Senior Director will manage the NPD quality engineering resources and allocates across NPD projects as needed to support business objectives. This individual will monitor quality metrics across the business unit to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed. He/she will partner with R&D, Operations, Regulatory & Marketing to assure there is appropriate execution of design controls and process validation for new products. The Senior Director will act as the site management representative and is responsible for the Management Review for Trauma. He/she will partner with MD&D functions including Supplier Quality and Manufacturing, to ensure Trauma's Quality strategy is aligned with MD&D Quality strategies. In addition, this individual will lead FDA/BSI and other foreign regulatory authority audits for Trauma.

Qualifications


A Bachelor's Degree in a technical discipline is required. A Master's Degree is preferred. A minimum of 10 years of business experience is required. A minimum of 5 of years in Quality, Regulatory or a related discipline within Medical Device is required. A minimum of 5 years people management or project management experience is required. NPD Quality Experience specific to QSR Design Control requirements is required. Direct experience leading Notified Body/FDA audits is required. Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required. Ability to effectively present complex information in a clear and concise manner is required. The ability to lead change initiatives associated with integration activities is preferred. Strong skills with a proven track record in managing process validation and failure mode effects and analysis is required. Previous experience managing multiple projects is a required. Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required. Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required. Experience of developing concise and audience-focused communications, both written and for presentations is required. Excellent communication and interpersonal skills are required.

This position will be based in West Chester, PA and requires up to 10% travel..

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Primary Location:North America-United States-Pennsylvania-West Chester
Organization: DePuy Synthes, LLC (6149)
Travel:Yes, 10% of the time