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Post Market Surveillance Quality Engineer 3
Requisition ID: 5553170711
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 Joint Reconstruction is the Orthopaedic division offering a comprehensive portfolio of Orthopaedic Implant solutions for the treatment of the simplest to the most complex joint disorders using traditional and minimally invasive techniques.
The Post Market Surveillance Quality Engineer 3 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. The individual will execute the Post-Market Surveillance process with a primary focus on signal assessment and detailed investigations and reports of potential Safety Issues and Quality Trend Events. This position will lead efforts in support of the business as it develops and implements product-specific safety surveillance strategies in proactive and systematic detection and evaluation of potential safety signals and emerging trends from post-marketing safety surveillance data. 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 Product Escalation group to ensure all events are escalated in a timely manner and per procedure. You will 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.
- A minimum of a Bachelor's degree in an Engineering, Technical, or Scientific discipline is required.
- 5 years of experience preferably within a regulated environment (e.g. FDA regulated) is required.
- An Advanced degree in a related field is preferred.
- 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 is required.
- 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.
- You will be based in Warsaw, IN, and will require up to 10% travel.
Depuy Orthopaedics. Inc. (6029)