Service and Repair Sr. Quality Engineer

Johnson & Johnson•Danvers, MA

37d•Hybrid

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â 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.â Learn more at https://www.jnj.com 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 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. A key feature of this role is the high degree of change management that will occur through the assignment.

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 independent learner and critical thinker with an eye for detail.
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.
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.
Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.
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.
Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed.
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.
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
Fluent in English. Additional language capability is a plus, especially German and Japanese.

Nice To Haves

Preferred: Master's degree in business, science, engineering, or a related scientific discipline.
IT Systems and Computer System Validation
Six Sigma methodology
EN ISO 13485
EN ISO 14971
QSR 21 CFR 801; 803; 806; 807; 820; 821; 830; 860
EU MDR 2017/745 & Directive EEC/93/42
MDSAP

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.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours

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