DePuy Synthes, the Orthopaedics Company of Johnson & Johnson is recruiting for a(n) Quality Engineer II - Post Market Surveillance (PMS), located in Raynham, MA (preferred), West Chester, PA or Warsaw, IN.
DePuy Synthes, the Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive Orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are crafted to advance patient care while delivering clinical and economic value to health care systems worldwide.
Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic 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.
Minimum of a Bachelor's Degree (B.S.) in a technical field is required; a degree in Engineering is preferred.
Experience and Skills:
- A minimum of 2 years experience working in a quality system framework (ISO 9001 or similar)
- Excellent problem solving and decision making skills
- Ability to work independently while collaborating with a multi-function team
- Proficiency with Microsoft Office Suite
- Medical device/diagnostic/or pharmaceutical industry experience
- Prior experience with Post Market Quality data and activities
- Working experience with statistics and analytical tools
- Problem solving techniques including root cause analysis and cause and effect analysis
- Design control experience with knowledge of interpreting product specifications
- Working knowledge of the Quality Systems Requirements
- Basic understanding of programming languages (R and RStudio in particular)
Must be proficient is both written and verbal communication with the English language.
This position may require up to 10% domestic travel, with an outside chance of international travel.
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.