Назад
Company hidden
4 дня назад

Sr Supplier Quality Engineer (MedTech)

79 000 - 127 650$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Sr Supplier Quality Engineer (MedTech): Leading supplier quality assurance for contract manufacturing sites and raw material suppliers supporting medical device production, with an accent on supplier non-conformities, CAPA, audits, process validation, and regulatory compliance. Focus on managing supplier changes, investigations, quality agreements, performance metrics, and cross-functional remediation projects.

Location: Palm Beach Gardens, Florida, United States of America

Base pay: $79,000–$127,650 per year

Company

Johnson & Johnson MedTech develops less invasive and personalized medical treatments and solutions.

What you will do

  • Lead supplier quality assurance for contract manufacturing sites and raw material suppliers supporting medical device production.
  • Manage supplier non-conformities, SCARs, CAPAs, change requests, quality agreements, and supplier assessments.
  • Support supplier process validations, product validations, first article inspections, control plans, capability studies, and PLM changes.
  • Contribute to product and process investigations, supplier audits, regulatory inspections, and supplier transfer projects.
  • Report supplier performance metrics and participate in quality projects involving legacy review, remediation, integration, and standards improvement.
  • Collaborate with Quality, Engineering, R&D, Regulatory, Sourcing, suppliers, and government or notified-body agencies.

Requirements

  • Bachelor’s degree or equivalent in Engineering, Life Science, or a related field.
  • 2–4 years of experience in a GMP- and/or ISO-regulated industry.
  • Strong communication, teamwork, problem-solving, analytical reasoning, and root cause analysis skills.
  • Ability to work effectively in a fast-paced environment and collaborate across functions.
  • Fluent written and spoken English required.
  • Up to 10% travel may be required.

Nice to have

  • Medical device or pharmaceutical industry experience.
  • Knowledge of FDA and ISO regulations, including FDA CFR Part 820 and ISO 13485.
  • Experience with machining, injection molding, robotics, electronics, software, operations supplier quality, or auditing.
  • Six Sigma, Lean, or ASQ certification and professional licenses.
  • Management or supervision experience.

Culture & Benefits

  • Full-time employment with vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.
  • Eligibility to participate in the company’s long-term incentive program.
  • Inclusive work environment focused on diversity, dignity, and equal opportunity.
  • Work includes compliance with health, safety, environmental, and applicable federal, state, local, and company regulations.

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 →