Quality Engineer II - Post Market Surveillance (PMS) (1 of 2) - Johnson and Johnson

DePuy Synthes is recruiting for a Quality Engineer II - Post Market Surveillance (PMS) that will generate and coordinate risk management, data analysis, and other activities within the Post Market Surveillance Department of DePuy Synthes. This position will be located in one of the following locations:

• Raynham, MA
• West Chester, PA
• Warsaw, IN
• New Jersey

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

The Quality Engineer II - PMS role will perform post-market safety and surveillance activities including trend analyses, signal assessments and product investigations. They will complete the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events. The Quality Engineer II - PMS will also connect and engage 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 detailed investigations and continuous improvements as needed. The investigations can include user interviews and customer visits to ensure rapid response to field safety issues.

This is a hands-on position that will require a self-motivated individual with excellent written and oral communication skills. This role will have the ability to collaborate with business partners at all levels with multiple functional groups in an environment that adopts collaboration and risk-based decision making.
Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Complete the defined PMS process
• Investigate and lead detailed collection of internal and external data on product safety and performance
• Lead and facilitate multi-functional product reviews
• Identify potential product performance issues early and raise appropriately
• Prepare reports on PMS related activities as required per PMS plan
• Assist in developing and implementing continuous improvements within policies and procedures
• DePuy Synthes job descriptions may be revised at management's discretion, at any time.
• Assist with DePuy Synthes Operating Companies post market surveillance initiatives
• Assist with CAPA activities as needed
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor

Education:

• University/Bachelors or equivalent degree in a technical field is required.

Experience and Skills

Required:

• A minimum of two (2) years of related work experience
• Experience working in a quality system framework (ISO 9001 or similar)
• Excellent problem solving and decision-making skills
• Proficiency with the Microsoft Office Suite

Preferred:

• Medical device/diagnostic/or pharmaceutical proven experience
• Root cause analysis skills
• Experience with Post Market Surveillance/Safety Surveillance activities
• Previous Design Control experience
• Solid understanding of reading and interpreting product specifications
• Experience with statistics/analytics and programming languages
• Strong working knowledge of the QSR and ISO quality requirements
• Knowledge of process or design excellence tools with Green or Black Belt training

Other:

• The anticipated base pay range for this position is $61,000 to $97,750.

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.

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.