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Supplier Quality Engineer

80 000 - 105 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
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
Supplier Quality Engineer (Biotech): Managing supplier qualification, audits, quality investigations, and performance improvement for a global supplier base with an accent on regulatory compliance, risk mitigation, and supplier accountability. Focus on evaluating manufacturing processes, leading SCAR and root-cause activities, assessing supplier changes, and coordinating quality improvements across Engineering, Operations, Sourcing, and Regulatory teams.

Location: Waltham, MA or Hopkinton, MA, United States; travel to supplier locations as required.

Salary: $80,000–$105,000 annually, plus eligibility for variable cash programs and, for eligible roles, equity.

Company

hirify.global develops technologies and solutions for bioprocessing and the production of biologic drugs.

What you will do

  • Evaluate and qualify new and existing suppliers, including manufacturing processes, capabilities, quality systems, and compliance.
  • Plan and conduct supplier audits, document findings, assess risks, and follow up on corrective actions.
  • Lead supplier nonconformance investigations and SCARs, including root cause analysis and effectiveness verification.
  • Assess supplier change notifications and coordinate quality and regulatory impact reviews.
  • Monitor supplier performance through scorecards, NCMRs, SCARs, audits, and other quality indicators.
  • Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams on validations, supplier changes, and quality improvements.

Requirements

  • Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent experience.
  • At least 2 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
  • Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
  • Working knowledge of quality management systems and GMP and FDA requirements.
  • Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
  • Strong problem-solving, analytical, communication, and cross-functional collaboration skills.

Culture & Benefits

  • Cross-functional and collaborative work with Quality, Sourcing, Engineering, Operations, and Regulatory professionals.
  • Paid time off.
  • Health, dental, and vision benefits.
  • Retirement benefits and flexible spending accounts.
  • Eligibility for variable cash programs and equity for eligible roles.

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