Johnson & Johnson Careers
Quality Systems Manager
Requisition ID: 1668180517
Here at DePuy Synthes Companies of Johnson & Johnson, we are seeking a Quality Systems Manager to join our team in Monument, CO.
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.
As the Quality Systems Manager, you will be responsible for leading the activities of Quality System associates and handling the CAPA, Complaints, Field Actions/Stop Shipment, and Document Control systems.
Position duties & responsibilities:
- You will lead and oversee the CAPA program in Monument
- You will be responsible for CAPA metrics
- Execution and development of CAPA capabilities across campus
- Management and oversight of Complaints in Monument
- Ensure the timely and accurate completion of complaint investigations
- Field Actions/Stop Shipment
- Management and oversight of Field Actions and Stop Shipments
- Responsible for Document Control and development of document control staff
- Handles delegation of tasks and projects to staff
- Responsible for the timely execution and reporting of Management Review progress reports
- Owns the implementation and administration of quality management systems in accordance with applicable standards
- Communicates business needs regarding procedures and processes for recording, evaluating, and reporting on quality and reliability. Requests data and metrics reports obtained from quality databases and files for inclusion in management reports
- Partners with compliance and operations partners to ensure site inspection readiness across the campus
- Management of monthly Compliance Metrics across the site
- Responsible for deployment of JNJ standards throughout the campus
- Partners with Quality System Operations in Depuy Synthes networks across US and EU
- Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions
- A minimum of a Bachelor’s Degree is required; degree in Engineering or related technical field preferred
- A minimum of 8 years of related experience required, preferably in a GMP and/or ISO regulated industry
- A minimum of 4 years’ experience with direct people management is preferred
- Experience working in both an FDA and European regulatory environment is required
- Experience managing CAPA process is required
- Relative experience in manufacturing/operations is preferred
- Product/process Risk Management experience is preferred
- Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies, including Measurement System Analysis, SPC, DOEs, Reliability, etc., is preferred
- Knowledge of statistical software packages with the ability to preview, graph, analyze, and present data in a way that facilitates/drives decision-making is preferred
- Ability to solve problems and perform "hands on" troubleshooting is required
- Technical understanding of manufacturing equipment and processes is preferred
- This position is located in Monument, Colorado and will require up to 25% travel domestically
Do you strive to join an outstanding team that is dynamic and ever-growing? Does the opportunity to work in an exciting environment in a beautiful location appeal to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)