Integrated Resources

QA Engineer III

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Job Location

Travelers Rest, SC, United States

Job Description

Job Title: QA Engineer III
Location: Greenville, SC 29611
Duration: 12 Months+

Shift Hours: 8 AM to 5 PM (Mon - Fri)

Job Description:
  • Looking for someone with medical device experience. (anyone from a big med device company) Root cause analysis.
  • Candidate will coordinate with engineering manager as well.
  • Software validation & involved in the design process of medical device.
  • Who is comfortable with Auditing FDA & ISO.
  • Pure manufacturing facility in Greenville, SC. 4 people in Quality team.

Roles and Responsibilities:
  • Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
  • Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
  • Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
  • Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
  • May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

Qualifications:
  • At least 3 years of experience required.
  • Bachelors required (Science is preferred).
  • Working with CAPA Managing risk management IVDR, ISO 1345, 21CFR 820 need to do.
  • Good at presenting data and willing to work with everyone on the floor for corrective action.
  • They will be coordinating with cross functional teams.


Location: Travelers Rest, SC, US

Posted Date: 11/29/2024
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Posted

November 29, 2024
UID: 4919323356

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