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Quality Systems Team Leader
West Chester, Pennsylvania
Requisition ID: 9463180419
DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Systems Team Leader to be 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.
You'll be responsible for the supervision of Quality Systems employees and Quality Systems activities. Areas of responsibility within Quality Systems may include, Document Control, CAPA, Complaint Handling, Audit Management, and Management Review.
- We are counting on you to lead personnel and activities to establish and maintain quality systems for stock evaluation/ hold/releases, field actions, customer complaints, and CAPAs
- Ensure Document Control, Complaint Handling, and other activities are performed in an accurate and timely manner.
- Coordinate and participate in plant Quality Progress Reports and Quality System Management Reviews; maintain and report metrics to demonstrate state of control within quality systems.
- You'll lead the Document Control personnel and activities to update and maintain Work Instructions, Training Guides, Forms, and manufacturing related documents as they apply to the Change Management process. This includes leading the electronic archiving procedures for all applicable documentation.
- Lead the site activities related to the customer complaint handling and investigations.
- Lead the site activities for CAPA processes including oversight of: owner assignments, root cause analysis, CAPA plan development, and verification of completion/ effectiveness while being responsible for the overall timeliness of the site’s CAPA activities.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Promote and demonstrate the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
- Participate in ongoing 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.
- Lead the preparation, coordination, and execution of any internal and/or external audits.
- A minimum of a Bachelor Degree is required preferably in Engineering, Quality or a related STEM field.
- 6 years Quality experience in a GMP and/or ISO regulated environment is required.
- 2 years of supervisory (direct/indirect/project management) experience is required.
- Experience in the Medical Device and/or Pharmaceutical industries is preferred.
- Experience with CAPAs, Audits, and Inspection Management support is required.
- Experience with Management Review, Complaints, Non-Conforming Materials, and Document Control sections of Quality Systems Regulation is preferred.
- Direct interaction experience with the US FDA or third-party inspectors during investigations is preferred.
- Demonstrated ability to work across all levels including executive management and production associates is required.
- High level of initiative and ability to work independently with minimal supervision is required.
- Data analysis and experience with basic statistical tools is required.
- ASQ Quality Auditor, ASQ Quality Engineer, Process Excellence and/or Project Management certifications are preferred.
- Strong communication, influencing, and negotiating skills.
- Strong organizational skills.
- This position will be based in West Chester, PA and may require up to 10% travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson &Johnson Family of Companies are equalopportunity employers, and all qualified applicantswill receive consideration for employment withoutregard to race, color, religion, sex,sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law
United States-Pennsylvania-West Chester
Depuy Orthopaedics. Inc. (6029)