DePuy Synthes, companies of Johnson & Johnson, is recruiting for a Senior Quality Engineer - New Product Development, 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.
The Senior Quality Engineer - New Product Development should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. They will:
Support new product development and design through verification and validation activities.
Support design control activities for new product development efforts.
Lead design transfer to manufacturing
Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions.
Develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams.
Provide leadership in the understanding of medical device regulations to other disciplines.
Communicate 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 is required.
A Bachelor's Degree in an Engineering or Scientific discipline is required. An Advanced Degree in a related field is 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 is preferred.
Experience in New Product Development of regulated devices is preferred.
Experience conducting Process/Design Failure Mode Effects and Analysis is an asset.
Experience with injection molded products is preferred.
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.
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.
Process Excellence/Lean experience is preferred.
This position will be based in Raynham MA and will require 10% travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Primary Location United States-Massachusetts-Raynham-325 Paramount Drive Organization Depuy Orthopaedics. Inc. (6029) Job Function Quality (Eng) Requisition ID 1852180911