Johnson & Johnson Careers

Post Market Surveillance Quality Engineer 2

Warsaw, Indiana
Quality (Eng)

Job Description

Requisition ID: 5188180307

DePuy Synthes Companies of Johnson & Johnson is seeking a Post Market Surveillance Quality Engineer 2  to be located in Warsaw, IN.
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.
The Post Market Surveillance Quality Engineer 2 should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This role predominantly performs Post-Market Surveillance activities, including trend analyses, signal assessments and investigations. Extensive knowledge and use of Excel is required. The individual will execute the Post-Market Surveillance process with a primary focus on signal assessment and detailed investigations to identify potential Safety Issues and Quality Trends. This position will lead efforts to develop and implement product-specific safety surveillance strategies. You will also prepare Safety Signal Reports for Leadership, as well as prepare Post Market Surveillance data and analysis for reviews with Business Unit Leadership teams. Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer will be the key interface with the other departments to ensure all events are escalated in a timely manner and per procedure. You are able 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, Technical, or Scientific discipline is required.
  • 2+ years of experience is required, preferably within a regulated environment (e.g. FDA regulated).
  • An Advanced degree in a related field is an asset.
  • Advanced knowledge and use of Microsoft Excel (macros, tables, look-ups, etc.) for data analysis is required.
  • 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.
  • Experience in monitoring or supporting clinical studies 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.
  • You will be based in Warsaw, IN, 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.
Johnson & Johnson Family of Companies areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
Primary Location
United States-Indiana-Warsaw
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)
Requisition ID