Johnson & Johnson Careers
Staff Quality Engineer
Requisition ID: 1699190410
DePuy Synthes Companies of Johnson & Johnson is hiring for a Staff Quality Engineer out of our West Chester, PA location.
DePuy Synthes Companies of Johnson & Johnson is the largest and most comprehensive orthopaedic and neurological business in the world. We 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 extraordinary companies, we are building one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop creative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Staff Quality Engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. You should be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
Your responsibilities will include, but are not limited to:
- Evaluating events and trends within the quality system, to assure safety, efficacy, and quality of products throughout their lifecycle through Health Risk Evaluations
- Presenting Health Risk Evaluations and Quality Review Board investigations weekly to executive management
- Ensuring that risks associated with products are identified and assessed throughout the product lifecycle
- Documenting these assessments in a timely and compliant manner
- Directly supporting and presenting these activities in internal and external quality system inspections
- A Bachelor's degree in an Engineering, Technical, or Scientific discipline required. An Advanced degree in a related field is an asset.
- A minimum of 8 years of experience within a regulated environment (e.g. FDA regulated) required.
- You should have the ability to work independently and partner with a multi-functional team.
- Quality Engineering/Design or Process Excellence/Lean experience is an asset.
- ASQ certifications are an asset.
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Mechanical product knowledge is preferred.
- Problem solving techniques including root cause analysis and cause and effect analysis are all preferred.
- Statistical techniques and methods are preferred. Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.
- Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
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.
United States-Pennsylvania-West Chester-1210 Ward Avenue
Depuy Orthopaedics. Inc. (6029)