J&J Family of Companies Quality Systems Engineer in Monument, Colorado
DePuy Synthes, a Johnson & Johnson company is hiring a Quality Systems Engineer located in Monument, Colorado.
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 Quality Systems Engineer will provide quality systems expertise in support of Quality Systems and Processes, including Corrective and Preventive Action (CAPA), Complaint Handling, Management Review, and Quality metric reporting.
The Quality Systems Engineer will provide quality systems guidance and support to the Complaint Handling and Corrective and Preventive Action (CAPA) processes. The Quality Systems Engineer will collaborate with representatives from other functional areas to facilitate timely and effective Complaint Handling investigations and Corrective and Preventive Action (CAPA) investigations, action plan implementation and effectiveness monitoring. The Quality Systems Engineer will collaborate with representatives from other functional areas to facilitate timely and accurate Manufacturing Investigations and Device History Reviews.
The Quality Systems Engineer will serve as a CAPA Subject Matter Expert (SME) and will monitor, analyze, and report Quality Management System metrics relating to the Complaint Handling and CAPA systems. The individual will work on complex investigations and will coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification of complaint investigation. The Quality Systems Engineer will support the facilitation of the CAPA Review Board (CRB) as needed, will provide back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits), and will provide training regarding Complaint Handling and CAPA related Quality Management System Elements to representatives from other functional areas.
The Quality Systems Engineer will identify opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives, as well as taking ownership of Complaint Investigation coordination and CAPAs impacting the CAPA Quality System. She/ he will support and participate in cross-functional projects when assigned, will facilitate technical innovations to enhance Quality Systems and support business goals, and will assist with other Quality System activities as requested by management.
The Quality Systems Engineer will lead high impact projects within the group and assume the trainer/mentor role for new engineers in the CAPA, Complaint Handling and Quality Systems processes
A minimum of a Bachelor’s Degree is required. A degree concentration in Science or Engineering is preferred.
A minimum of 4 years of experience in Quality and/or Compliance within the Medical Device Industry and/or Pharmaceutical Industry is required.
Specific experience in corrective and preventive action efforts is required.
Experience with EtQ Instinct CAPA module is preferred.
Working knowledge of 21 CFR Part 820 and ISO 13485 is required.
A certification in Process Excellence (e.g. Green Belt) is an asset. Experience with front and back room is strongly preferred.
A demonstrated proficiency in process improvement methodology and use of investigative tools (Cause and Effect Diagrams, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.) are preferred
Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
Organizational and communication skills providing the ability to multi-task in a fast- paced environment are required.
This position will be based in Monument, CO and may require up to 10% domestic and/ or international 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 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)