QA Specialist

3 weeks ago


Austin, United States Collabera Full time
Job DescriptionJob DescriptionJob Description:Roles and Responsibilities:
  • This position will support 3rd party for medical devices, device history records and mostly will handle Batch Records.
  • Must have Bachelor’s degree preferably in STEM Engineering / Science degrees are best fits.
  • Must have a minimum of 3 years of experience in a medical device or pharma regulated environment, preferably in manufacturing.
  • HEAVY Documentation role doing batch review, quality doc approvals Documentation exp. on Resume review of quality documents batch release experience or lab notebook (design, manufacturing or release).
  • Experience in nonconformances and CAPA is a plus.
  • Must have strong attention to detail. Must know and be able to follow procedures, review document requirements and determine if acceptable for procedure and if not escalate.
  • Internship, co-ops and schooling will not be considered.
  • Masters degrees will not supplant any years of experience so must still come with minimum 3 years of experience.
Top 3 Skills:
  • Ability to follow procedures
  • Strong attention to detail
  • Strong understanding of med device quality docs.
Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.

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