Quality Assurance Supervisor-9591140716
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Assurance Supervisor in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic 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 Assurance Supervisor will supervise, coordinate and facilitate personnel and activities to establish and maintain quality systems for stock evaluation/ hold/ release, recall, customer complaint, nonconforming materials and CAPA. This includes trending, analysis and reporting of quality metrics. Coordinate and participate in plant Management Reviews. Manage projects and interact with other site or corporate personnel as required. Provide a contact point for all Recalls/ Stock Evaluations/ Stock Holds for Brandywine product monitoring appropriate and timely completion of investigation, analysis, bounding, corrective action and documentation.
The Quality Assurance Supervisor will administer and coordinate the customer complaint handling system, database and activities through the QE/ME groups by logging, distributing, tracking and reporting on complaint evaluations. Administer the Non-Conforming Material system and database for logging, tracking and reporting. Facilitate CAPA initiations, owner assignments, root cause analysis, CAPA plan development, and verification of completion/ effectiveness. Administer the CAPA program including weekly meetings and status reports. Maintain and track CAPA status activities. Prepare monthly and quarterly reports, data analysis and trending for management and for inclusion within the CAPA system, e.g. scrap, rework, etc. Assist Plant Manager with organizing the quarterly Management Review. As appropriate, assure action items are addressed through the CAPA system.
The Quality Assurance Supervisor will participate in on-going identification of quality indicators/ metrics and development of improved data collection methods. Lead continuous quality system improvement efforts, including developing project plans and maintaining project schedules. Perform or coordinate software validation as needed for supporting queries, system upgrades, etc. Assist, as necessary during FDA investigations or other compliance audit and follow-up activities. Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities. Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer. Performs other duties as assigned.
Qualifications
To be considered for the role a minimum of a Bachelor Degree in Engineering, Quality, Systems or a related technology field is required. A minimum of 6 years Quality Assurance experience is required. A minimum of 3 years of supervisory experience is required. A minimum of 3 years of experience in the Medical Device or Pharmaceutical industries is preferred. In-depth understanding of Management Review, CAPA, Complaint and Non-Conforming Materials sections of Quality Systems Regulation. Direct interaction experience with the US FDA during investigations is desirable. Demonstrated project management and organization skills, including the ability to lead special projects and manage multiple tasks simultaneously. Demonstrated ability to work with executive management and floor worker positions. High level of initiative and ability to work independently with minimal supervision. Application of advanced computer skills including queries, data analysis and basic statistical tools is required. Strong verbal/written communications skills. Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
This position will be located West Chester, PA and will require up to approximately 10% travel.
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Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Travel:Yes, 10 % of the Time
Job Function: Quality Assurance
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