Service and Repair Sr. Quality Engineer

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

We are searching for the best talent for a Service and Repair Sr. Quality Engineer role to be located at Danvers, MA.

Due to significant growth, Abiomed is working to develop and enhance Commercial and Service and Repair (S&R) capabilities globally, including Quality 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 Abiomed field S&R and supporting S&R base business quality operations activity. The incumbent will complete Quality responsibilities in the Service & Repair center following standard operating procedures to ensure compliant, and efficient activities with an unwavering focus on customer experience.

Essential Duties and Responsibilities

• Provides direct Quality support for S&R Operations owned escalation, non-conformance, CAPA and change control processes in North America and LATAM and indirectly to other global regions.

• Supports S&R operations during internal and external auditing and inspection.

• Supports implementation of processes, systems, resources, and SOPs, for the organization aligning with the J&J policies, J&J standards, applicable regulations and training requirements.  Identifies risks, develops proposals and options, and builds consensus with key stakeholders on the determined solutions.

• In partnership with S&R Operations, implements 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

• Other activities as required by management.

Special requirements:

• Technical knowledge in applicable regulations, quality systems and operations for medical device service and repair and distribution activities including distribution, storage, transportation.

• Must possess a diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, storage, and distribution

• Knowledge of Quality IT Systems

Other features of the job:

• A key feature of this role is the high degree of change management that will occur through the assignment.

Job location:

• Danvers/Peabody MA, USA (J&J Flex 3 days on-site per week with the option to work up to 2 days remote).  Role will move from Danvers to Peabody aligned with S&R Operations timeline.

Requirements

• 5+ years of work experience in a highly regulated industry with the ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and internationally. The ideal candidate is an i