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Quality Engineer II
Requisition ID: 0159180118
DePuy Synthes Spine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II, located in Raynham, MA.
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.
DePuy Synthes Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.
The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility.
You will work in a design team setting. Primarily, you will support design control activities for commercialized products. This role will be responsible for activities related to maintaining safe and effective product in the field including but not limited to design changes, supplier transfers, DHF remediation, risk benefit analysis development, test method development and investigations related to non-conformances, CAPA or audit observations. This person will also be responsible for developing risk assessment, inspection methodology and acceptance criteria for inspection sample plans. This person also might support quality engineering activities related to new product development on an as-needed basis. He/she will provide leadership in the understanding of medical device regulations to other disciplines. The Quality Engineer II will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, Medical Affairs and Marketing.
- A minimum of a Bachelor's degree in a Technical or Scientific discipline is required.
- A minimum of 2 years of experience is required, preferably in a highly regulated industry.
- Medical Device and/or Pharmaceutical industry experience is preferred.
- An advanced degree in a related field is an asset.
- Quality Engineering/Process Excellence/Lean experience is preferred.
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Mechanical product knowledge is preferred.
- Experience with Blueprint reading/literacy including GD&T is preferred.
- Familiarity with inspection methods and techniques is an asset.
- Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.
- Strong proficiency with the Microsoft Office Suite is required.
- Excellent problem solving, decision-making skills and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
This position will be based in Raynham, MA, and will 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.
Depuy Orthopaedics. Inc. (6029)