Johnson & Johnson Careers
Senior Design Quality Engineer
Requisition ID: 1905734897W
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we created one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
Senior Design Quality Engineer
- Design Quality team member focused on life cycle management activities.
- Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
- Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
- Conduct and lead design verification and validation activities.
- Conduct and lead design / process failure mode effects and analysis.
- Work closely with suppliers on the qualification of new parts and processes supporting product development
- Conduct assessments of new suppliers as part of the project teams.
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Post Market Surveillance, Nonconforming Materials, Risk Management, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field is required. A Master’s degree in a technical discipline is an asset.
Excellent problem solving, decision-making, and root cause analysis skills are required.
- Interpersonal skills that foster conflict resolution are required.
Experience with Blueprint reading/literacy including GD&T is required.
- Proven track record implementing Quality System improvements to meet compliance and overall business goals.
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
- Previous Quality Engineering experience is preferred.
- Previous experience in a medical device or a healthcare discipline is preferred.
- Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
- Working knowledge of material science and mechanical product knowledge is preferred.
- Development and manufacturing experience is preferred.
- Knowledge of process and design excellence tools is strongly preferred.
- Process Excellence certification is an asset.
- Fluency in English is required, good knowledge of German would be a strong asset.
Synthes GmbH (7111)