Quality Assurance Specialist

4 weeks ago

Arden Hills, Minnesota, United States Advantage Technical Full time

Supplier Remediation Engineer

Advantage Technical is seeking a highly skilled Supplier Remediation Engineer to join our team. As a key member of our supplier engineering team, you will be responsible for remediation activities identified for contract manufactured (CM) sourced finished medical device (SFMD) product.

Key Responsibilities:

  • Review and remediate CM SFMD supplier's process risk documentation to newly defined criteria.
  • Review and remediate CM SFMD supplier's process and inspection validations to the company's statistical requirements.
  • Perform change management activities to remediate gaps found in CM SFMD Supplier's process risk documentation and process/inspection validations.
  • Collaborate with CM SFMD suppliers and the company's functional resources to complete all activities needed to approve supplier's process risk documentation and process/inspection validations to the newly defined criteria.

Requirements:

  • Bachelor's degree in engineering or a related field.
  • 1 – 2 years of experience in a manufacturing environment.
  • Experience working in the Medical Device Field.
  • Ability to travel up to 15% of the time.
  • Experience working with suppliers or in supply chain management.
  • Excellent communication and project management skills.
  • Strong bias for action and results oriented.
  • Self-driven and self-motivated to learn and apply knowledge to produce results.
  • Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Preferred Qualifications:

  • Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
  • Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.

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