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3 дня назад

Document Control Administrator (Medical Devices)

20 - 23$
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
Document Control Administrator (Medical Devices): Supporting quality documentation administration for medical device and specialized battery manufacturing with an accent on controlled records, GMP, QMS compliance, and document lifecycle management. Focus on implementing change records, reviewing Device History Records, controlling document access and distribution, and supporting quality audits.

Location: Plymouth, Minnesota, United States; onsite

Salary: $20.23–$29.67 per hour

Company

hirify.global provides medical device technologies and specialized batteries for energy, military, and environmental applications.

What you will do

  • Support documentation administration activities within the Quality function under defined procedures and moderate supervision.
  • Administer change record implementation and control the distribution, retrieval, access, and storage of controlled documents.
  • Notify relevant functions about changes to local external documents and perform annual record disposition reviews.
  • Compile and review quality records, reports, documentation, and Device History Records in accordance with GMP and applicable procedures.
  • Provide data and analysis to other departments and assist the Quality department during audits.
  • Identify and escalate quality non-conformances while supporting process quality improvements.

Requirements

  • High school diploma or equivalent may be required; administration experience is preferred.
  • 2–3 years of experience, with the ability to work under moderate supervision.
  • Strong written and verbal communication, organization, time management, prioritization, and attention to detail.
  • General computer skills, including Microsoft Teams, Excel, and Word.
  • Working knowledge of electronic documentation systems and office administration.
  • Understanding of Quality Management Systems, including ISO 9001, ISO 13485, and FDA 21 CFR Part 820.

Culture & Benefits

  • Values-driven environment focused on customer success, innovation, collaboration, inclusion, candor, and integrity.
  • On-the-job training, cross-training, and classroom instruction to expand skills.
  • Medical, dental, vision, disability, life insurance, and adoption benefits with immediate eligibility.
  • Paid time off, 80 hours of company-designated holidays, and parental leave after one year.
  • 401(k) plan with company matching contributions and access to incentive, overtime, shift differential, and call-in pay where applicable.

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