Quality Systems Manager-2472140818
Description
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems Manager. This is position will be located in West Chester, PA or Raynham, MA.
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.
The Quality Systems Manager will provide ongoing strategic review and continuous improvement of the Legacy Synthes Quality System in line with Franchise and Sector standardization initiatives utilizing robust project management methodologies. Actively engage in quality system management activities in terms of product safety, field action management, quality system and compliance improvement, inspection management, business solution innovation, and customer facing quality improvement opportunities.
The Quality Systems Manager will develop and drive improvement in the Quality System supporting the Global Orthopaedic organization specifically NCR, Management Review, Escalation, Trending, Quality Planning and Failure Investigation. Carry out strategic planning and development process on a continuous basis, analysis, definition and PMO leadership. He/she will have identification and leadership of tactical continuous improvement opportunities. Collate and analyze the relevant information through Management Review to facilitate a review of the performance and suitability of the QMS. Collaborate with business partners to develop and implement innovative business solutions. Carry out quality system due diligence and integration activities as required by the business. Active engagement with external regulatory authorities, including performing lead and support roles as required for Legacy Synthes QA during external inspections. Provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies in Global Orthopaedics.
The Quality Systems Manager will partner on the formulation of responses to regulatory agencies in order to address QMS related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions. Standardize and leverage MD&D compliance policies, practices, metrics and resources across the sector in alignment with the enterprise standards. Ensure emerging regulatory requirements are addressed in a proactive and effective manner. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings. Support Global Orthopaedics objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure. Develop Quality Organization Structure to support US Legacy Synthes Quality Management System. Ensure effective recruitment/organizational development for all direct reports. Perform financial planning and overall budget management. Perform all other work related duties. Represent Quality as required on quality and business teams throughout Global Orthopaedics and MD&D.
Qualifications
To be considered for the role a minimum of a Bachelor’s Degree or US equivalent is required, preferably in Engineering, Scientific or Quality discipline. An Advanced degree in Quality or Regulatory is preferred. A minimum of 8 years Quality Systems experience in a healthcare regulated industry is required. A minimum of 3 years experience in a direct people management capacity is required. A broad based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance is required. A good working knowledge of related functions such as Operations, Product Development and Procurement is required Experience within a FDA QSR and/or ISO environment is required. A working knowledge of PAL and other related medical device national regulatory standards is desired. Demonstrated knowledge of business impact of compliance issues and risk management is required. Demonstrated effective people management in multiple locations is desired. Experience in preparing for audits in multiple locations is required. Experience in managing external third party for audits in multiple locations is desired. A Process Excellence Black Belt Certification is desired.
A candidate should also possess excellent communication skills. He/she should have strong collaboration and influencing skills. He/she should have team building and development capabilities, along with system design and management skills – Organizational and Quality Systems. He/she will have an expert knowledge of the US FDA Quality System Regulations and ISO, along with a demonstrated track record of delivering best in class results in the Quality Systems area.
This position is located in West Chester, PA or Raynham, MA and will require up to 30% travel including international.
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Primary Location:North America-United States-Pennsylvania-West Chester
Other Locations:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Travel:Yes, 25 % of the Time
Job Function: Quality Systems
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