DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Quality Engineer – CAPA Processes to be located in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies 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. 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 Senior Quality Engineer – CAPA Processes will provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant with DePuy Synthes standards and Medical Device Regulations.
- The Senior Quality Engineer – CAPA Processes will support the implementation of the standardized procedures, processes and systems for CAPA.
- He/she will deliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA content.
- This individual will assist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination.
- The Senior Quality Engineer – CAPA Processes will maintain overall management and effectiveness of the CAPA system including the process and application for applicable location.
- He/she will roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes.
- This individual will ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA.
- The Senior Quality Engineer – CAPA Processes will provide CAPA compliance metrics and weekly management tracking reports.
- He/she will implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management.
- This individual will facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems.
- The Senior Quality Engineer – CAPA Processes will liaise with US CAPA Manager in establishing and implementing DePuy Synthes policies, procedures, and quality objectives as well as to align on system requirements to support the CAPA process.
- He/she will be expected to identify and lead tactical, continuous improvement opportunities for procedural harmonization and integration. This individual will support audit readiness for CAPA. The Senior Quality Engineer – CAPA Processes will partner on the formulation of responses to regulatory agencies in order to address CAPA related observations.
- Collaborate in the identification and implementation of corrective actions. He/she will ensure effective and timely completion of all corrective actions.
- He/she will be responsible to 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.
- This individual will diligently participate in our compliance program-related activities as denoted by his/her supervisor or our Chief Compliance Officer.
- A minimum of a Bachelors Degree is required.
- A Bachelors Degree in Engineering, a Life Science or a related technical discipline is preferred.
- A minimum of 4 years in a GMP and/or ISO regulated environment is required.
- Experience working in a Medical Device manufacturing environment is preferred.
- Strong knowledge of quality and compliance for Medical Device Industry (GMPs) is preferred.
- Working knowledge of complaints and regulatory issues are preferred.
- Working knowledge of FDA Quality System Regulations is required. Experience with ISO 9001/ISO 13485 standards is preferred.
- Working knowledge of Japanese Regulatory Requirements (JPAL) and other related medical device national regulatory standards is preferred.
- Demonstrated knowledge of business impact of compliance issues and risk management is required.
- Proven ability to build partnerships both internally and externally is required.
- Prior Project Management skills are preferred.
- Experience or training and/or certification in Process Excellence/Six Sigma are preferred. Strong communication, organizational, negotiation and interpersonal skills are required.
- The ability to collaborate with all levels of management across multiple sites and functions is required.
- A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement is preferred.
- This position will be based in Monument, CO and require up to 15% travel, including possible international travel.
Johnson & Johnson is an equal opportunity employer Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function