Sr. Quality Engineer

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 Med Tech, 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.

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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.

Supply Chain Engineering

Quality Engineering

Scientific/Technology

Danvers, Massachusetts, United States of America, Woburn, Massachusetts, United States of America

We are searching for the best talent for a Sr. Quality Engineer
, located in Danvers, MA or Woburn, MA
.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Learn more at

In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring that high standards of product quality, compliance, and patient safety are maintained.

The successful candidate must be comfortable working across functional boundaries and adapting responsibilities to support changing operational and Quality priorities.

• Document production nonconformity, conduct investigation, assess product risk, recommend disposition in collaboration with other members of MRB.
• Define and implement action plans and effectiveness monitoring for CAPA originated from Internal/external audits.
• Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
• Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Support process validations/revalidation on current and new processes. (IQ, OQ, PQ)
• Support incoming inspection department as needed.
• Collaborate with equipment department for PM and calibration procedural updates. Support for non-conformities from failed calibration, etc.

• Bachelor's degree in Engineering or a related technical field and 2-4 years of relevant Quality Engineering or related experience.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Proven track record to work independently and manage multiple tasks effectively.
• Excellent problem-solving skills and a proactive approach to challenges.
• Strong communication skills, with the ability to mentor and lead teams effectively.

• Working knowledge of SAP.
• Preferred certifications: ASQ Certified Quality Engineer (CQE).
• Knowledge of electrical systems, Schematic drawing and IPC 610 is a plus.
• Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR. ISO 13485 Internal audit certificate is a plus.

• Understand…