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Staff Engineer, External Manufacturing and Supplier Quality (MedTech)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Staff Engineer, External Manufacturing and Supplier Quality (MedTech): Leading supplier qualification, quality systems, audits, risk mitigation, and continuous improvement across an external manufacturing network with an accent on medical device quality systems, purchasing controls, and regulatory compliance. Focus on investigating supplier nonconformances, improving process capability, implementing supplier-related changes, and using performance data to strengthen product quality and supply chain reliability.

Location: Jacksonville, Florida, United States of America. Full-time role with standard weekday business hours; up to 30% travel may be required.

Company

Johnson & Johnson MedTech develops healthcare and vision solutions, combining biology, technology, and medical innovation to improve patient outcomes.

What you will do

  • Lead qualification, oversight, and performance management for suppliers and external manufacturers.
  • Drive quality, compliance, continuous improvement, and operational excellence across the supply network.
  • Develop and improve supplier quality systems, processes, metrics, and performance initiatives.
  • Conduct supplier assessments, audits, and technical reviews to verify capability, compliance, and improvement opportunities.
  • Identify and mitigate supply chain quality risks, investigate supplier nonconformances, and resolve supplier-related issues.
  • Partner with internal and external stakeholders to implement supplier changes, strengthen process capability, and support purchasing controls.

Requirements

  • Bachelor’s degree in arts, science, or an equivalent field.
  • 4–6 years of related professional experience in a regulated industry.
  • Foundational understanding of medical device quality systems, particularly purchasing controls.
  • Proficiency in Microsoft Word, PowerPoint, and Excel, including moderately complex data analysis and trend identification.
  • Ability to provide technical leadership, coaching, problem-solving, and quality support.

Nice to have

  • Experience in the medical device, pharmaceutical, chemical, packaging, or plastics industry.
  • Knowledge of FDA and ISO regulations, including 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 9001, Canadian CMDCAS, Japanese PAL, Anvisa, or Australian TGA requirements.
  • Experience with Lean supply chain management, quality validation, GAMP, and quality systems documentation.

Culture & Benefits

  • Inclusive work environment based on individual dignity, diversity, and merit.
  • Work focused on healthcare innovation and improving vision treatment outcomes.
  • Collaboration with global suppliers, technical teams, and business partners.
  • Opportunity to influence supplier performance, regulatory compliance, and product quality across the value chain.

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