Senior Quality Engineer

ÞPuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, Product Escalation, located in Raynham, MA, Raritan, NJ, Warsaw, IN, West Chester, PA or Palm Beach Gardens, FL! DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. The Senior Quality Engineer (Product Escalations) will have responsibility for driving product quality issues through the decision-making framework of risk management boards and quality review boards. To succeed in the role, you are structured, detailed, quality-conscious, and promote risk-based decision making. You are adaptable and solution oriented and are happy to come up with new insights. As a person, you are driven and proactive, have a good ability to work independently as well as collaborate with team members. The work requires that you are detailed, flexible and enjoy working according to set time targets. The pace of work can sometimes be high, and it is important that you can plan your work while at the same time be open and flexible for re-prioritization. Key Responsibilities: Facilitate teams of multi-functional SMEs to complete root cause investigation and bounding, to assess regulatory and medical safety impact and review associated quality system records and risk documentation Lead weekly reviews on open investigations with SMEs and representatives of the risk management board (RMB), drive timely actions and updates, facilitate identification of higher risk issues as early as possible, communicate to management on high-risk safety, quality or compliance issues Lead RMB and Quality Review Board (QRB) meetings; prepare presentations of each issue and guide quorum to a final vote; complete records and meeting minutes in a timely manner, route records for approvals Liaise with field action team to ensure transition of QRB actions and documentation Support Data Requests for post market surveillance, regulatory registrations, etc Support internal and external audits in preparation activities, backroom and front room roles Complete special assignments across DPS and/or HMD initiatives as requested Qualifications Education: A minimum of a Bachelor's degree Required: A minimum of 5 years of experience in a highly regulated environment Experience with root cause investigations and associated bounding Knowledge and experience with Microsoft Office software as well as intermediate to advanced software skills with Microsoft Excel and PowerPoint. Excellent problem-solving skills, self-motivated, able to work efficiently independently and in a team environment Able to progress work forward in the face of ambiguity Open to 10% travel as needed Preferred: A Bachelor of Art or Science Degree in Science/Technical Field Medical Device experience Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment Quality Engineering/Design or Process Excellence/Lean Experience, ASQ or Six Sigma Certification, mechanical product knowledge Experience in manufacturing and/or mechanical knowledge Project management experience Excellent interpersonal relations and decision-making skills that further conflict resolution to technical situations Others Require up to 10% domestic travel At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-Massachusetts-Raynham-325 Paramount Drive Other Locations North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw, North America-United States-New Jersey-Raritan, Latin America-Mexico-Chihuahua-Juarez, North America-United States-Florida-Palm Beach Gardens Organization Medical Device Business Services, Inc (6029) Job Function Engineering Requisition ID 2206055388W