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11 дней назад

Quality Control Reviewer, 2nd Shift (MedTech)

Формат работы
onsite
Тип работы
fulltime
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
Quality Control Reviewer, 2nd Shift (MedTech): Reviewing and releasing medical device batch records and associated quality documentation with an accent on compliance, document accuracy, and electronic record management. Focus on identifying discrepancies, reviewing certificates and inspection reports, maintaining Excel tracking records, and completing documentation within production schedules.

Location: Audubon, Pennsylvania, United States; onsite, 2nd shift

Company

Develops medical devices and surgical solutions designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

  • Review and release medical device batch records according to applicable release criteria.
  • Review certificates of compliance, test reports, and receiving inspection documentation.
  • Report non-conformances and discrepancies.
  • Record review activities in Excel and scan, file, and log completed quality documents in the electronic record system.
  • Meet production-schedule targets while following safety precautions, SOPs, and applicable regulations.

Requirements

  • At least one year of experience with document review.
  • High school diploma or equivalent.
  • Proficiency in Microsoft Office, especially Excel.
  • Strong organizational, problem-solving, follow-up, multitasking, and attention-to-detail skills.
  • Ability to sit, climb or balance, stoop, kneel, crouch, or crawl; regularly lift or move up to 10 pounds and occasionally up to 25 pounds.

Nice to have

  • Familiarity with GMP and SOPs aligned with ISO standards.

Culture & Benefits

  • Work within a quality assurance operations department supporting medical device production.
  • Follow a values-driven culture focused on innovation, customer service, teamwork, and results.
  • Complete introductory and annual compliance training.
  • Reasonable accommodations are available for individuals with disabilities.

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