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9 дней назад

Staff Supplier Quality Engineer

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Singapore
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 Supplier Quality Engineer (Supplier Quality/IVD): Improving supplier material quality and compliance for genomic technology products with an accent on corrective actions, supplier development, audits, and regulated quality systems. Focus on resolving supplier quality issues, qualifying new suppliers, analyzing processes, and preventing defects across the supply base.

Location: Singapore - Woodlands - NorthTech

Company

hirify.global develops genomic technologies that support early disease detection, diagnosis, treatment development, and broader health equity.

What you will do

  • Lead supplier quality activities to improve material quality and prevent non-conforming parts from entering production.
  • Build and manage long-term relationships with sub-assembly suppliers and develop their ability to meet quality requirements.
  • Drive supplier improvement projects using process analysis, value stream mapping, process capability analysis, Six Sigma, 5S, and Kaizen.
  • Establish supplier quality goals, monitor performance metrics, and ensure timely corrective actions and issue resolution.
  • Evaluate and qualify new suppliers and materials through the product development process.
  • Conduct supplier audits and travel internationally to resolve quality problems and verify compliance.

Requirements

  • 8+ years of quality assurance experience in a regulated environment; IVD manufacturing experience is preferred.
  • Bachelor's degree with 8 years of related experience, Master's degree with 6 years, PhD with 3 years, or equivalent experience.
  • Experience with 21 CFR 820, ISO 13485, ISO 14971, IVDD, ISPE Baseline Guides, and ASTM E2500-07.
  • Practical experience with design controls, risk management, validation, change control, supplier quality, CAPA, and failure investigations.
  • Experience with SPC, Six Sigma, risk analysis, FMEA, DOE, and trend analysis.
  • Strong communication, cross-functional collaboration, independent working ability, and willingness to travel internationally.

Nice to have

  • Quality certification such as CQE.
  • Experience in IVD manufacturing.

Culture & Benefits

  • Inclusive environment focused on belonging, collaboration, and alternative perspectives.
  • Employee Resource Groups provide career development, cultural awareness, and social responsibility opportunities.
  • Commitment to pay equity and equal employment opportunity.
  • Background checks are conducted after a conditional offer.

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