Manufacturing Engineer II

4 weeks ago


Saint Paul, Minnesota, United States US Tech Solutions Full time
Job Summary:

This position is responsible for remediation activities identified by CAPA 7720 for BSC's contract-manufactured (CM) sourced finished medical device (SFMD) product. The ideal candidate will work independently, serve as a leader for SE remediation activities, and interact cross-functionally with BSC team members and CM SFMD suppliers to execute deliverables according to business needs.

Key Responsibilities:
  • Review, remediate, and approve CM SFMD supplier's process risk documentation to newly defined criteria.
  • Review, remediate, and approve CM SFMD supplier's process and inspection validations to BSC's statistical requirements.
  • Perform change management activities to remediate gaps found in CM SFMD Supplier's process risk documentation and process/inspection.

Requirements:
  • Bachelor's degree in engineering or a related field.
  • 1 – 2 years of experience in a manufacturing environment.
  • Ability to travel up to 15% of the time.

Preferred Qualifications:
  • Experience working with suppliers or in supply chain management.
  • Experience working in the Medical Device Field.
  • Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. We are an Equal Opportunity Employer and welcome qualified applicants from diverse backgrounds. We are committed to maintaining a workplace that is free from discrimination and harassment. If you are a qualified candidate, please submit your application for consideration.

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