9 часов назад
Senior Quality Engineer NPI LCM (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Quality Engineer NPI LCM (Medical Devices): Supporting the quality and reliability of new medical device introductions and lifecycle management with an accent on design controls, risk management, verification, validation, and regulatory compliance. Focus on developing inspection and sampling plans, validating test methods, solving product and process quality issues, and mentoring Primary Quality Engineers.
Location: Irving, Texas, United States of America; onsite
Company
Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare solutions across medical technology and aesthetics.
What you will do
- Support new product launches from concept and design through development, stabilization, and steady-state production.
- Drive product requirements, verification strategies, validation strategies, and quality activities across the product lifecycle.
- Ensure compliance with GMP, ISO standards, FDA design-control requirements, company procedures, and applicable regulations.
- Develop inspection and sampling plans, test methods, transfer functions, and validation approaches for products and processes.
- Provide statistical support, analytical problem solving, risk management, and support for CAPA, complaints, post-market surveillance, and audits.
- Collaborate with R&D, Regulatory Affairs, Medical Affairs, Manufacturing, Operations Quality, Marketing, and other partners; mentor Primary Quality Engineers.
Requirements
- Bachelor’s degree in engineering, science, or a related technical field from an accredited university.
- At least 5 years of experience in a regulated industry and prior experience in Quality Engineering.
- Experience with new product development and/or lifecycle management.
- Knowledge of FDA requirements for medical device design control.
- Experience participating in risk management discussions and working in team-based environments.
Nice to have
- Relevant advanced degree.
- Experience with Class III medical devices.
- ASQ Certified Quality Engineer or Certified Reliability Engineer certification.
- Green Belt in DMADVV, DMAIIC, Lean, or another Process Excellence roadmap.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and individual contribution.
- Cross-functional collaboration across medical, regulatory, manufacturing, quality, and commercial teams.
- Commitment to an inclusive interview process and applicant accommodations.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →