Service and Repair Sr. Quality Engineer

Johnson & Johnson•Cherry Hill, NJ

6d•Hybrid

About The Position

This role is responsible for supporting multiple workstreams in the development and enhancement of Commercial and Service and Repair (S&R) capabilities globally, including Quality support to these functions. The focus is on the 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.

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.
Fluent in English.

Nice To Haves

An advanced degree in a related field or equivalent direct work experience in Service & Repair and/or Quality Compliance is also an asset.
Master’s degree in business, science, engineering, or a related scientific discipline.
Additional language capability is a plus, especially German and Japanese.
Knowledge 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

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.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year