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2 дня назад

Senior Supplier Quality Engineer (Medical Devices)

100 000 - 130 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Supplier Quality Engineer (Medical Devices): Ensuring supplier quality, Quality Management System compliance, and regulatory compliance for clinical diagnostic instruments with an accent on supplier qualification, audits, corrective actions, and material control plans. Focus on resolving supplier-caused manufacturing issues, visiting suppliers to address product performance concerns, recommending field actions, and leading Kaizen events to reduce variation and waste.

Location: On-site in Chaska, Minnesota, United States

Salary: $100,000–$130,000 per year, plus bonus or incentive pay.

Company

Beckman Coulter Diagnostics is a hirify.global operating company that develops clinical diagnostic solutions used in hospitals, research laboratories, reference laboratories, and physician offices.

What you will do

  • Plan and organize supplier selection and qualification, change notifications, audits, corrective actions, and supplier scorecards.
  • Develop supplier material control plans during product qualification.
  • Represent supplier quality in root-cause and corrective-action investigations for supplier-related manufacturing issues.
  • Visit suppliers to resolve product performance concerns.
  • Recommend appropriate field actions to the product regulatory committee.
  • Lead Kaizen events to reduce variation, implement lean processes, eliminate waste, and improve production efficiency.

Requirements

  • Scientific degree in a relevant field such as mechanical, electrical, or chemical engineering.
  • At least 5 years of quality experience with a bachelor's degree.
  • At least 3 years of quality experience with a master's degree or doctoral degree.
  • Experience ensuring compliance with quality management systems and regulations.

Nice to have

  • Certified Quality Engineer certification.
  • Experience with 21 CFR 820 and ISO 14971.

Culture & Benefits

  • Cross-functional and collaborative work environment.
  • Opportunity to build world-class medical devices and improve diagnostic healthcare.
  • Paid time off.
  • Medical, dental, and vision insurance.
  • 401(k) for eligible employees.

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