Johnson & Johnson Careers

Manager, Quality Systems Operations

West Chester, Pennsylvania
Quality Assurance


Job Description

Requisition ID: 0074180430

DePuy Synthes Companies of Johnson & Johnson is seeking a Manager, Quality Systems Operations 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.
The Manager, Quality Systems Operations will be responsible for managing all quality assurance functions and providing quality systems oversight at the Wilson Drive manufacturing site, including, Management Review, CAPA, Complaints, Field Actions/Stop Shipment, Document Control, Quality Engineering, and Inspection.
Position duties & responsibilities:
  • Leads the implementation and administration of quality management system in accordance with applicable standards.
  • Drive compliance with regulatory and company quality requirements for products, components, and raw materials.
  • You will handle and oversee CAPA program for Wilson Drive, including metrics, and execution and development of CAPA capabilities across campus.
  • Run and lead Complaints process for Wilson Drive, and ensure complaint investigations are completed in a timely manner.
  • Manage and oversee Field Actions and Stop Shipments.
  • Manage and oversee Document Control activities.
  • Communicate business needs regarding procedures and processes for recording, evaluating, and reporting quality and reliability. Request data and metrics reports obtained from quality databases and files for inclusion in management reports.
  • Examines results from management reviews, third party inspections, and internal audits, and approves proposed corrective actions.
  • Partners with compliance and operations partners to ensure site inspection readiness.
  • Partners with Quality Operations in DePuy Synthes network across US and EU.
  • Actively lead team by setting standards for performance, performing assessments, providing feedback, delivering effective communications, and promoting employee morale.
  • Acts as a technical/quality reference regarding quality issues as needed.

Qualifications
  • A Bachelor’s Degree in STEM discipline is required. An MBA is an asset.
  • A minimum of 8 years’ quality experience in a GMP and/or ISO regulated industry is required. Medical Device and/or Pharmaceutical industry experience is highly preferred. 3D Printed Products / Additive Manufacturing experience is an asset.
  • A minimum of 2 years of direct people management experience is required with a demonstrated track record for coaching, talent development, and performance management.
  • Demonstrated ability to work across all levels including executive management and production associates is required.
  • Product/Process Risk Management experience is required.
  • Experience managing CAPA and Audits is required.
  • The ability to perform “hands on” troubleshooting and problem solving and ability to take initiative with an innovative approach in a fast-paced, changing business environment is required.
  • ASQ Quality Auditor, ASQ Quality Engineer, Process Excellence and/or Project Management certifications are preferred.
  • Experience working in manufacturing/operations is preferred.
  • Advanced Technical Training and/or experience using Statistics, Lean, and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc. is preferred.
  • Direct interaction and experience with US FDA or third-party inspectors during investigations is preferred.
  • The 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 Companiesare equal opportunity employers, and allqualified applicants will receive considerationfor employment without regard to race,color, religion, sex, sexual orientation, genderidentity, genetic information, national origin,protected veteran status, disability status,or any other characteristic protected bylaw.
Primary Location
United States-Pennsylvania-West Chester
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID
0074180430