Sr Quality Systems Engineer, Product Escalation & Field Actions

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America, Remote (US)

Job Description:

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr Quality System Engineer, Product Escalations & Field Actions position, located in Danvers, MA.

Remote work options may be considered on a case-by-case basis and if approved by the company.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This exciting opportunity will allow the individual to not only collaborate across the Abiomed business for day-to-day operations but also will regularly communicate and interact with leaders within J&J MedTech and Abiomed. This position will support and drive end-to-end process execution to achieve sustained success and serve as a subject matter expert.

This individual should excel in an environment that embraces teamwork, change, risk-based decision-making, multi-tasking and flexibility. They should be ready to make a significant contribution to a dynamic, multi-disciplinary team, where a self-motivated individual with excellent written and verbal communication skills stands ready to succeed. You'll need to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, Supplier Quality, and Medical Safety. Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!

Key Responsibilities:

• Support, coach and mentor Abiomed teams, as well as liaison with leadership and supporting functions, to ensure execution of the Product Issue Escalation and Field Action processes in compliance with MD and J&J standards.
• Provide end-to-end process support by facilitating teams of multi-functional SMEs resulting in successful completion of escalation product issue assessments and subsequent field actions as applicable while using the applicable technology platform (ETQ).
• Facilitate teams of multi-functional SMEs in support of developing Field Action strategies, customer communication packages, and/or other elements of Field Action execution.
• Lead/support weekly reviews on open investigations with SMEs and representatives of the risk management board (RMB),
• Drive timely end-to-end actions and updates, including facilitating identification of higher risk issues as early as possible, communicate to management on high-risk safety, quality or compliance issues.
• Prepare and complete end-to-end process documentation and records in a timely and compliant manner. This includes supporting the preparation of presentations throughout the processes.
• Communicate effectively at all levels within Quality as well as business partners within departments such as Medical Safety, R&D/Engineering, Regulatory, Supplier Quality, Manufacturing, and Marketing.
• Responsible for communicating business related issues or opportunities to next management level.

Qualifications

Education:

• A minimum of a Bachelor's or equivalent degree is required; Scientific and/or Engineering discipline is preferred.

Required:

• A minimum of 2-4 years of related work experience
• 2+ years of related experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry
• Ability to work independently and support global, multi-functional teams through collaboration and cross-functional tasks and decisions
• Ability to work in fast paced environment with rapidly shifting priorities while maintaining high attention to detail.
• Project