Quality Assurance Specialist

2 weeks ago

Eden Prairie, Minnesota, United States Moffat Workforce Full time

Quality Assurance Specialist – Direct Hire

Company: Moffat Workforce

We are seeking a qualified candidate to join our team as a Quality Assurance Specialist. The ideal applicant will possess a minimum of 2 years of experience in quality assurance within the medical device industry, along with a solid grasp of ISO 13485 standards.

Key Responsibilities:

  • Execute functional assessments in accordance with component specifications, production guidelines, and testing protocols.
  • Oversee incoming inspection processes, ensuring all necessary documentation and requirements are met for the release of parts and components.
  • Conduct in-process and final inspections of components, sub-assemblies, and finished products.
  • Prepare non-conformance reports for any parts that do not meet established specifications or requirements.
  • Assist in troubleshooting, investigations, and resolution of issues and non-conformances.
  • Ensure compliance with quality systems documentation and maintain accurate record-keeping as per established procedures.
  • Perform additional tasks as assigned by the supervisor.
  • Develop and document quality system procedures as needed.
  • Provide assistance during customer audits.
  • Support the supervisor in the preparation of management reviews.

Qualifications:

  • At least 2 years of relevant experience in the medical device sector and familiarity with ISO 13485.
  • High School Diploma required; a two-year degree is preferred.
  • Experience in electronics manufacturing is advantageous.
  • Strong mathematical and technical abilities.
  • Proficient in computer applications, particularly MS Office.
  • Familiarity with quality management systems, including electronic quality management software, is preferred.

The compensation for the Quality Assurance Specialist role is competitive and commensurate with experience.

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