Service and Repair Quality Engineer

Role Summary

We are seeking a Service and Repair Quality Engineer to be located in Danvers, MA. The role supports Commercial Quality and Service & Repair (S&R) operations, focusing on implementing Johnson & Johnson standards for Abiomed field S&R and supporting S&R base business quality activities to ensure compliant, efficient operations with a strong emphasis on the customer experience. Location is in Danvers, MA with a transition to Peabody, MA as the S&R timeline progresses; on-site work is three days per week with the option to work up to two days remotely.

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.

Qualifications

• Required: 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 independent learner and critical thinker with an eye for detail.
• Required: This role requires a diverse business background, with specific quality and regulatory compliance competencies in the areas of medical device manufacturing, medical device capital equipment service and repair.
• Required: Experience in positions of increasing responsibility supporting multi-site, global organizations, with broadly based quality or operations experience inclusive of non-conformance, CAPA, change control and audit/inspection management.
• Required: Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.
• Required: Builds consensus and impacts outcome without always having line authority and can negotiate trade off decisions across the organization. Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• Required: Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed.

Education

• Required: A minimum of a bachelor’s degree in engineering or scientific discipline is required. An advanced degree in a related field or equivalent direct work experience in Service & Repair and/or Quality Compliance is also an asset.
• Preferred: Master’s degree in business, science, engineering, or a related scientific discipline.

Skills

• Decisive, organized, and able to lead people within a complex global environment.
• Excellent communication / presentation skills, able to inspire trust and quickly build credibility within the 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. Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Engages in open and honest communications to ensure effective change management.
• Fluent in English. Additional language capability is a plus, especially German and Japanese.
• Preferred: IT Systems and Computer System Validation
• Preferred: Six Sigma methodology
• Preferred: EN ISO 13485
• Preferred: EN ISO 14971
• Preferred: QSR 21 CFR 801; 803; 806; 807; 820; 821; 830; 860
• Preferred: EU MDR 2017/745 & Directive EEC/93/42
• Preferred: MDSAP