Quality Systems Expert

Описание

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Johnson & Johnson MedTech Cardiovascular: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. We are looking for a Quality Systems Expert to support, maintain, and continuously improve Quality Management System. In this cross-functional role, you will help ensure that quality records, training activities, and core quality processes remain compliant, reliable, accessible, and sustainable. You will work with stakeholders across the site, provide user support for key quality systems, and contribute to audit readiness and process improvement in a regulated environment.

Responsibilities

• Support key quality processes and continuous-improvement activities, including CAPA, non-product nonconformances, DRB, QSMR, ICQAs, periodic reviews, and audits
• Support Quality Systems training projects and initiatives, including curricula, user groups, training assignments, and training-plan updates
• Provide day-to-day support to users of the Learning Management System and Agile PLM
• Partner with departments and business units to meet records-retention, legal-hold, and vital-record requirements
• Maintain accurate, complete, protected, and retrievable paper and electronic records throughout their lifecycle
• Coordinate active and inactive record storage, offsite archiving, required metadata, and tracking of archive boxes
• Communicate business issues and improvement opportunities to the appropriate management level
• Follow all applicable company, quality, safety, environmental, and regulatory requirements
• Performs other duties assigned as needed

Requirements

• At least 3 years of experience in a regulated quality environment – mandatory
• Degree in engineering or life science - advantage
• Comfort working with computerized systems and Microsoft Office
• Strong English skills and the ability to review technical documents in English

Nice to have

• CQE certification – significant advantage
• Experience with Agile PLM, eTQ, an LMS, or another quality system is an advantage

We offer

• Hybrid Work
• Full time

Hiring process

• Application deadline: December 31, 2026