DePuy Synthes, Inc. is recruiting for a Quality Engineer II, Post Market Surveillance, in Raynham, MA.
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 Engineer will generate and coordinate Post Market Surveillance activities within the Post Market Surveillance Department and also perform sustaining Design Quality Engineering activities within the Design Quality Engineering Department of DePuy Synthes. The Engineer will have responsibilities within DePuy Synthes Spine to drive compliance for Post Market Surveillance activities, the Safety Surveillance Initiative and for sustaining Quality Engineering activities.
• Perform post-market safety and surveillance activities including trend analyses, signal assessments and product investigations
• Execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events.
• Interface with key business partners and coordinate activities as determined by the Safety Surveillance process of Product Development, Medical Affairs, Regulatory Affairs, Operations, Marketing, and the Complaint Handling departments to ensure thorough investigations.
• Investigations can include user interviews and customer visits to ensure rapid response to field safety issues
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.
• Bachelor’s Degree in a Engineering or related field
• 2 years’ experience working in a quality system framework (ISO 9001 or similar)
• Proficiency with the Microsoft Office Suite
• Excellent problem solving and decision-making skills
• Ability to travel up to 10% domestic & possibly international travel
• Advanced Degree
• Medical device/diagnostic/or pharmaceutical industry experience
• Root cause analysis skills
• Experience with Post Market Surveillance/Safety Surveillance activities.
• Previous Design Control experience
• Working knowledge of reading and interpreting product specifications
• Experience with statistics/analytics
• Strong working knowledge of the QSR and ISO quality requirements
• Knowledge of process or design excellence tools with Green or Black Belt training
Medical Device Business Services, Inc (6029)