DePuy Synthes Companies of Johnson & Johnson is seeking a CAPA / NC Lead to be located in Warsaw, IN.
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 Lead Supply Chain (SC) CAPA Owners to effective, efficient and compliant CAPA management.
Lead Non-Conformance Owners to effective, efficient and compliant NC management.
Lead Supply Chain (SC) Audit Owners to effective, efficient and compliant Audit management.
Responsible for the generation, reporting and accuracy of monthly Supply Chain metrics.
Act as voting member of Warsaw CAPA Review Board.
Develop engaged CAPA and NC culture in Warsaw SC that is proactive and patient centric.
Lead Quality Progress Review (QPR) meetings by scheduling meetings, preparing for the meetings, collating deliverables from cross-functional teams, and reporting out meeting results.
Develop, implement and track CAPA Aging and Timeliness Report by Value Stream/Site.
Analysis of other sites’ SC CAPA trends for similarities or differences. Track and trend CAPA Root Cause to reduce recurrence rate. Identify and escalate systemic issues and propose/develop solutions.
Develop and implement an NC report that reduces resource requirements to produce while facilitating easier trending and tracking of issues. Report to facilitate numerous reporting metric requirements.
Assist in Deep Dive reviews of Human Error Related NCs to identify opportunity for Mistake Proofing opportunities. Track and trend NC root causes to reduce recurrence rate. Identify and escalate systemic issues and propose/develop solutions.
Monitor NC content for continued compliance. Address any non-conformances. Trend non-conformances for process/system improvements.
Provide feedback to system owners regarding EtQ applications and improvements. Participate/Input to WW Teams on CAPA and NC issues to develop and share best practices across all sites.
Partner with Franchise Compliance Organization to ensure harmonized approach.
Active input/engagement in weekly/monthly monitoring meetings/sessions.Qualifications
- A minimum of a Bachelors’ Degree is required.
- Generally requires 6+ years related experience.
- Experience working in a regulatory environment is required.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Proficiency in Failure Investigation and Problem Solving.
- In-Depth knowledge of Quality System procedures and regulations.
- In-Depth knowledge of the CAPA and Non-conformance process in required.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and ability to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is required.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Strong mentoring, coaching and leadership skills are required.
- Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
- Demonstrated project management and project leadership abilities are required.
- This position may require up to 10% travel and will be based in the Warsaw, IN manufacturing facility.
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 areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function
Quality (Eng)Requisition ID