Service and Repair Sr. Quality Engineer

Role Summary

Service and Repair Sr. Quality Engineer located in Danvers, MA. Focuses on implementing J&J standards compliance for Abiomed field S&R and supporting S&R quality operations, with direct involvement in quality processes and customer-focused outcomes.

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, aligning with J&J policies and standards; identifies risks and builds consensus on solutions.
• Implements aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of growth.
• Ensures appropriate self-training and development planning to support compliant operations within Commercial Quality.
• Other activities as required by management.

Qualifications

• 5+ years of experience in a highly regulated industry with clear communication skills; independent learner and detail-oriented.
• Diverse background with quality and regulatory competencies in medical device manufacturing, service and repair.
• Experience in multi-site, global organizations with non-conformance, CAPA, change control and audit/inspection management.
• Experience with global regulatory requirements across multicultural locations.

Skills

• Builds consensus and influences across the organization; strong collaboration and negotiation skills.
• Analytical and strategic thinking with ability to zoom in/out between strategic and tactical levels.

Education

• Required: Bachelor‚Äôs degree in engineering or scientific discipline. Advanced degree or equivalent experience in Service & Repair and/or Quality Compliance is a plus.
• Preferred: Master‚Äôs degree in business, science, engineering, or related field.

Additional Requirements

• Job location: Danvers/Peabody MA, USA; on-site 3 days/week with up to 2 days remote; role will move to Peabody aligned with S&R timeline.