Quality Engineer II, Post Market Surveillance

DePuy Synthes, the Orthopedics Company of Johnson & Johnson is recruiting for a Quality Engineer II, Post Market Surveillance (PMS) , located in Raynham, MA (preferred) or West Chester, PA.

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.

Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow.

Key Responsibilities :

This role will generate and coordinate PMS activities within the Post Market Surveillance Department; with the additional responsibility to drive compliance for Post Market Surveillance activities and all Regulatory Requirements.

The candidate will perform post market safety and surveillance activities including trend analyses, signal assessments and product investigations. They will execute the surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events. The position will also collaborate with key business partners and coordinate activities as determined by the Safety Surveillance process of Product Development, Medical Affairs, Regulatory Affairs, Operations, Marketing, and Customer Quality departments to ensure detailed investigations. The investigations can include user interviews and customer visits to ensure rapid response to field safety issues.

• Support and execute the defined PMS process within the Medical Device PMS team
• Lead and facilitate multi-functional product reviews
• Investigate and lead detailed data collection activities to assess product safety and performance
• Identify potential product performance issues early and raise appropriately
• Prepare reports on PMS related activities as required per PMS plans
• Assist with implementing continuous improvements within policies and procedures
• Establish and maintain effective working relationships with diverse groups of people in a global organization.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of integrity, ethics and compliance at all times.