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8 дней назад

Document Control Coordinator (Medical Devices)

42 075 - 61 710$
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
Document Control Coordinator (Medical Devices): Managing engineering, process, procedural, and design-change documentation for medical device manufacturing with an accent on document control systems, quality requirements, and production releases. Focus on maintaining electronic engineering records, preparing Bills of Materials and standard operating procedures, and coordinating change requests under FDA and quality management requirements.

Location: Minneapolis, Minnesota, United States; onsite

Salary: $42,075–$61,710 per year

Company

hirify.global develops and manufactures products for the medical device industry.

What you will do

  • Coordinate and process documentation for process, procedural, and design changes affecting parts and assemblies.
  • Organize and maintain files, records, and electronic engineering documentation systems.
  • Issue, expedite, and control final and revised prototype and production release documents.
  • Prepare change requests, special reports, Bills of Materials, routings, Standard Operating Procedures, and related process documentation.
  • Coordinate information flow, follow up on pending matters, and provide administrative support to the quality department.
  • Follow Quality Management Systems, Environmental Management Systems, FDA regulations, company policies, and applicable regulatory requirements.

Requirements

  • Two-year degree in a technical field or business.
  • Two to four years of experience, or a high school diploma with at least seven years of experience.
  • Strong computer skills and previous experience with engineering documentation control systems.
  • Strong verbal and written communication skills.
  • Ability to work onsite in Minneapolis, Minnesota, United States.

Culture & Benefits

  • Values-driven culture focused on customer success, innovation, collaboration, inclusion, candor, and integrity.
  • Medical, dental, vision, disability, life insurance, and adoption benefits with immediate eligibility.
  • Parental leave available after one year.
  • 401(k) plan with company matching contributions and immediate eligibility.
  • Paid time off and 80 hours of company-designated holidays annually.

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