[Hiring] Senior Quality System Engineer, Field Actions @Johnson & Johnson Innovative Medicine

Role Description

We are searching for the best talent for a Senior Quality System Engineer, Field Actions to be based in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the company.

This exciting opportunity will allow the individual to not only collaborate across the Abiomed business for day-to-day operations, but also will regularly communicate and interact with leaders within J&J MedTech and Abiomed. This position will support and drive end-to-end process execution to achieve sustained success and serve as a subject matter expert.

This individual should excel in an environment that embraces teamwork, change, risk-based decision-making, multi-tasking and flexibility. They should be ready to make a significant contribution to a dynamic, multi-disciplinary team, where a self-motivated individual with excellent written and verbal communication skills stands ready to succeed. You'll need to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, Supplier Quality, and Medical Safety. Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!

• 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.

Qualifications

• 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).

Requirements

• 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

Benefits

• 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