Commercial Quality Specialist

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

Johnson & Johnson is currently seeking a Commercial Quality Specialist, located in Danvers, MA or Peabody, MA to join our Abiomed Team. This role is currently located in Danvers, MA, but will relocate to Peabody, MA in 2027.

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

Due to significant growth, Abiomed is working to develop and enhance Commercial and Distribution capabilities globally, including Quality Operations support to these functions. The incumbent will be responsible for supporting multiple workstreams in support of this development activity, focused on implementation of J&J standards compliance for commercial operations, escalation and field action, 3PL logistics supplier quality, supplier quality management for distributors, storage, transportation, pick to order operations, repack/relabel, field service, product returns and material and product controls.

The incumbent will complete shop floor Quality responsibilities in the distribution center following standard operating procedures to ensure compliant, and efficient activities for the region, with an unwavering focus on customer experience.

Key Responsibilities:

• Partners with the Abiomed Commercial and Distribution organizations to define customer priorities and quality plans to achieve customer requirements, support growth and ensure compliant commercial and distribution operations.
• Completes commercial quality related escalations in accordance with Abiomed SOPs as directed.
• Executes Field Actions in accordance with Abiomed SOPs as directed.
• Performs shop floor Quality activities for all Peabody DC and Danvers related distribution, transportation, and customer service, including PTO (pick to order).
• Approves, leads, or assists in investigations of non-conformances, and corrective and preventive action (CAPA) for distribution/PTO, transportation, and customer service.
• Facilitates constructive interactions with suppliers to optimize logistics operations, encompassing effective communication, problem-solving, comprehensive training initiatives, and the deployment of new legislation and corporate requirements.
• Reviews and approves assigned related change controls for distribution, transportation, and customer service.
• Defines in collaboration with Abiomed Quality Management, processes, systems, resources, and SOPs, for the organization to align with the J&J policies, J&J standards, and applicable regulations. Develops proposals and options and builds consensus with colleagues on the solutions.
• Support implementation of the aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of substantial growth forecast for the Abiomed business.
• Ensures appropriate self-training is planned and achieved to support compliant operations within Commercial Quality. Ensures technical and business self-development through robust development planning and execution.
• Identifies and implements cost and efficiency opportunities in collaboration with business partners in support of the Patient First agenda.