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22 часа назад

Final Release Specialist (Medical Device Manufacturing)

22 - 31$
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
Final Release Specialist (Medical Device Manufacturing): Reviewing and completing manufacturing records and documentation for compliant batch final release with an accent on Device History Records, batch records, inspections, and regulatory requirements. Focus on tracking work-in-progress records, initiating nonconformances and CAPAs, resolving documentation issues, and coordinating release activities across Quality, Operations, Engineering, and other departments.

Location: Devens, MA, United States. Onsite first-shift role, Monday through Friday, 7:00am–3:30pm.

Hourly pay: $22–$31.

Company

hirify.global develops and operates industrially scalable laser metal additive manufacturing and precision machining capabilities for aerospace, defense, medical, and other essential industries.

What you will do

  • Set up, organize, review, and complete technical, batch, and final release records.
  • Assign and track work-in-progress records through completion and coordinate priorities with Program Managers.
  • Verify inspections, physical products, data entry, documentation, and final dispositions against specifications and requirements.
  • Identify, document, and report nonconformances, deviations, QA variances, and documentation errors.
  • Coordinate with Quality Assurance, Operations, Customer Service, Distribution, Engineering, and other departments to resolve issues and meet commitments.
  • Develop and release controlled work instructions and identify improvements to the Final Release process.

Requirements

  • 3+ years of experience in medical device manufacturing with direct responsibility for Final Release or Document Control.
  • Experience reviewing Device History Records and Batch Records for completeness and compliance.
  • Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.
  • Ability to read and interpret engineering drawings, blueprints, and technical specifications.
  • Knowledge of ERP and QMS electronic systems.
  • Ability to work onsite in Devens, Massachusetts, during the first shift.

Culture & Benefits

  • Medical, dental, vision, and life insurance.
  • Generous paid time off.
  • 401(k) plan with company match.
  • Competitive salary and equity package based on skills, qualifications, and experience.
  • Inclusive environment focused on quality, accountability, ownership, and continuous learning.

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