Senior Quality System Engineer, Field Actions

Johnson & Johnson Innovative Medicine•Danvers, MA

1d•$79,000 - $127,650•Onsite

About The Position

This exciting opportunity is for a Senior Quality System Engineer, Field Actions, to be based in Danvers, MA, with remote work options considered on a case-by-case basis. The role involves collaborating across the Abiomed business for day-to-day operations and regularly communicating with leaders within J&J MedTech and Abiomed. This position supports and drives end-to-end process execution to achieve sustained success and serves as a subject matter expert. The ideal candidate will thrive in an environment that embraces teamwork, change, risk-based decision-making, multi-tasking, and flexibility, making significant contributions to a dynamic, multi-disciplinary team. Excellent written and verbal communication skills are essential for effective communication at all levels within Quality and cross-functionally with departments such as R&D, Regulatory, Manufacturing, Supplier Quality, and Medical Safety.

Requirements

A minimum of a Bachelor's or equivalent degree is required; Scientific and/or Engineering discipline is preferred.
A minimum of 2-4 years of related work experience.
3+ years of related experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.
Ability to work independently and support global, multi-functional teams through collaboration and cross-functional tasks and decisions.
Ability to work in fast paced environment with rapidly shifting priorities while maintaining high attention to detail.
Project management skills including strong initiative and follow through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively.
Strong communication skills, capable to summarize & effectively communicate complex ideas, and skilled at refining technical information to accommodate broader audiences.
Knowledge and application of QSR/GMP/GCP/ISO regulations as related to medical device.
Working knowledge and practical application of 21 CFR Part 820 & 806, ISO 13485, and ISO 14971.
Proficient skills in Microsoft Office software, including PowerPoint and Excel.
Proficient in both verbal and written English communication.
Up to 20% Travel (national or international).

Nice To Haves

Analytical Reasoning
Business Alignment
Business Behavior
Coaching
Collaborating
Communication
Compliance Management
Data Compilation
Data Quality
Data Savvy
Document Management
Problem Solving
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
Systems Analysis
Training People

Responsibilities

Support Abiomed teams, as well as liaison with leadership and supporting functions, to ensure execution of the Field Action processes in compliance with MD and J&J standards.
Provide process support by facilitating teams of multi-functional SMEs resulting in successful completion of field actions as applicable while using the applicable technology platform (ETQ).
Facilitate teams of multi-functional SMEs in support of developing Field Action strategies, customer communication packages, and/or other elements of Field Action execution.
Drive timely actions and updates, including facilitating identification of higher risk issues as early as possible, communicate to management on high-risk safety, quality or compliance issues.
Prepare and complete process documentation and records in a timely and compliant manner. This includes supporting the preparation of presentations as needed throughout the processes.
Communicate effectively at all levels within Quality as well as business partners within departments such as Medical Safety, R&D/Engineering, Regulatory, Supplier Quality, Manufacturing, and Marketing.
Responsible for communicating business related issues or opportunities to next management level.

Benefits

Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year