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Senior Quality Engineer - New Product Development
Requisition ID: 0184180118
DePuy Synthes, companies of Johnson & Johnson, is recruiting for a SeniorQualityEngineer -NewProductDevelopment, 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 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, more agile and better equipped to meet the needs of 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 offers 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.
As a Sr. QualityEngineer-NewProductDevelopment, you should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. You must be willing to make a significant contribution to a multi-disciplinary team.
You will be responsible for leading: root cause investigation, failure mode effects analysis, design verification/validation testing, inspection method development, acceptance criteria creation and process validation/verification. The generation of protocols and reports to clearly document the previous design control activities is a key ability. You will also participate / lead the qualification and design transfer activities with external manufacturers of electro-mechanical devices.
You will conduct external audits of new suppliers as part of the new product development and internal audits of the quality system to assure alignment to corporate policies, internal standards/requirements and compliance with regulatory requirements. You'll also support the maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions.
We are counting on you to provide leadership in all areas of the Quality System, including, corrective & preventive actions, nonconforming materials, risk management, and medical device regulations. You'll need to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
- A minimum of a Bachelor's Degree in an Engineering or Scientific discipline is required, preferably in Electrical or Computer Science Engineering. An Advanced Degree in a related field or in electrical or computer engineering / computer science is also an asset.
- A minimum of 4 years experience in a highly regulated industry is required. Medical Device and/or Pharmaceutical industry is preferred.
- Quality engineering experience of electrical and software products in a regulated industry is highly preferred.
- Experience in New Product Development is preferred.
- Electrical and/or software product knowledge is preferred.
- Hands on experience with analog/digital circuits, electrical-mechanical drivers, schematic design, layout & programmable logic (FPGA/CPLD) is preferred.
- Experience designing test cases for software and electrical systems if highly preferred.
- Experience conducting Process/Design Failure Mode Effects and Analysis is an asset.
- Experience supporting or conducting Process Verification / Validation activities 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.
- Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required.
- Strong analytical, writing, and interpersonal skills is an asset. Prior project management experience is preferred.
- Demonstrated strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
- Process Excellence/Lean experience is preferred.
- This position will be based in Raynham MA, and will require 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)