Sr Service and Repair Quality Engineer

About Med Tech

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.

Abiomed is working to develop and enhance Commercial and Service & Repair (S&R) capabilities globally, including Quality support to these functions. The incumbent will support multiple work streams focused on implementing J&J standards compliance for Abiomed field S&R and base business quality operations activity. Responsibilities include performing direct Quality support for S&R Operations, managing escalation, non-conformance, CAPA, change control processes, and supporting internal and external audits.

• Provide direct Quality support for S&R Operations owned escalation, non-conformance, CAPA and change control processes in North America, LATAM, and indirectly to other global regions.
• Support S&R operations during internal and external auditing and inspection.
• Implement processes, systems, resources, and SOPs aligned with J&J policies, standards, applicable regulations and training requirements. Identify risks, develop proposals and options, and build consensus with stakeholders on solutions.
• Implement aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of substantial growth forecast.
• Plan and achieve appropriate self‑training to support compliant operations within Commercial Quality, and pursue technical and business self‑development through robust planning and execution.
• Other activities as required by management.

• Technical knowledge in applicable regulations, quality systems and operations for medical device service and repair and distribution activities including distribution, storage, transportation.
• Possess a diverse business background, with specific quality, regulatory and regulatory compliance competencies in commercial quality, supplier quality, storage and distribution.
• Knowledge of Quality IT Systems.

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 shift from Danvers to Peabody aligned with S&R Operations timeline.

• 5 years of work experience in a highly regulated industry with clear communication skills (oral and written) within internal project teams and internationally. Independent learner and critical thinker with an eye for detail.
• Specific quality and regulatory compliance competencies in medical device manufacturing, capital equipment service and repair, and multi‑site, global organizations.
• Experience supporting non‑conformance, CAPA, change control and audit/inspection management in a multi‑cultural, multi‑country setting.
• Experience with global demands of the role, including multi‑cultural/multi‑country locations and healthcare regulatory requirements.

• Build consensus and influence outcomes without line authority, negotiate trade‑offs across the organization, and collaborate across functions and operating units.
• Strong analytical and strategic skills with a bifocal approach – ability to zoom in/out for strategic and tactical, high‑level, and detailed focus.

• Required:
  
  Bachelor’s degree in engineering or a scientific discipline. Advanced degree in a related field or equivalent direct work experience in Service & Repair and/or Quality Compliance is an asset.
• Preferred:
  Master’s degree in business, science, engineering or a related scientific discipline.

• Decisive, organized, and able to lead people within a complex global environment.
• Excellent communication/presentation skills, inspiring trust quickly within Quality & Compliance, S&R, Supply Chain, and Commercial organizations.
• Hands‑on operational orientation focused on the customer. Accountability with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change.
• High tolerance for ambiguity.…