Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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. Learn more at https://www.jnj.com
Job Function:
Quality
Job Sub Function:
Quality Training
Job Category:
Professional
All Job Posting Locations:
Danvers, Massachusetts, United States of America
Job Description:
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
Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr Coordinator LMS Instructional Design position, located in Danvers, MA.
Job Summary:
We are seeking a Sr. Coordinator, Training and Instructional Design, to support a high-impact quality systems training function within a regulated medical device environment.
This role combines LMS administration, training records management, curricula optimization and compliance tracking, with development of instructional content.
- Executes as the administrator of the Learning Management System (LMS) for all US sites.
- Responsible for compliance tracking and communications for all US sites.
- Process owner for curricula management globally
- Process owner for the development of instructional material for GxP training.
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!
Key Responsibilities:
- Provide end-to-end training process support by collaborating with people managers resulting in successful completion of training assignments.
- Process owner for curricula management globally
- Administers training records and maintains the LMS (Learning Management System).
- Manage training project timelines and stakeholder communication to ensure on-time delivery and completion of training.
- Implement and monitor training metrics (completion, upcoming training) to assess training effectiveness and inform iterative improvements.
- Acts as training coordinator for change requests for all US sites.
- On site audit support in US for the training quality process for internal and external inspections, including training area resources and logistics.
- Design, develop, and maintain high-impact training materials for GxP using instructional design tools.
- Partner with subject-matter experts to translate complex process knowledge into clear, practical learning materials that support compliance and operational excellence.
- Incorporate future-ready digital skills and learning technologies to modernize training delivery and measurement.
- Responsible for communicating training related issues or opportunities to next management level.
- Executes any other activity as required by the Training Leader.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
Qualifications
Education:
- A minimum of a Bachelor’s or equivalent degree is required; Scientific and/or Engineering discipline is preferred.
Required:
- A minimum of 4-5 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 include strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively.
- Strong communication skills, capable of summarizing & effectively communicating 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.
Preferred Skills:
- Experience with ComplianceWire or other Learning Management Systems
- Digital learning technologies
- Critical Thinking
- Process Improvement
- Ability to influence cross-functional teams and drive quality culture.
Other:
- Proficient in both verbal and written English communication.
- Up to 20% Travel (national or international).
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Savvy, Compliance Management, Continuous Improvement, Continuous Quality Improvement (CQI), Data Reporting, Goal Attainment, Healthcare Facilities Management, Problem Solving, Process Optimization, Project Management, Quality Assurance (QA), Quality Control (QC), Quality Standards, Training Administration, Training Delivery Methods, Training Needs Analysis (TNA), Training People
The anticipated base pay range for this position is :
$94,350.00 – $127,650.00
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. • Employees and/or eligible dependents may be 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. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation – up to 120 hours per calendar year o Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time – up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
