Quality Assurance Specialist

6 days ago


Austin, Texas, United States Saxon Global Full time
Job Description

Job Title: Quality Operations Engineer II

Company: Saxon Global

Job Summary:

We are seeking a highly skilled Quality Operations Engineer II to join our team at Saxon Global. As a key member of our quality assurance team, you will be responsible for advising management on quality assurance requirements, reviewing non-conforming products, and performing product failure investigations.

Key Responsibilities:

  1. Participate in the nonconformance process to ensure timely completion of documentation stages.
  2. Identify, report, and monitor nonconforming events for the areas of responsibility.
  3. Perform product or process failure investigations and implement corrective and preventive actions to prevent reoccurrence.
  4. Interact with cross-functional teams to resolve quality issues.
  5. Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
  6. Develop Quality Instructions and Quality Standards.
  7. Support in the development, validation, and implementation of Test Methods.
  8. Suggest, implement, review, and approve engineering changes to support product life cycle.
  9. Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc.
  10. Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities.
  11. Collaborates with Manufacturing, Product Support, and R&D to support products for design and process improvements, and new equipment installations.
  12. Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
  13. Serve as a technical resource for assessing validation requirements, solving test-related problems, and developing strategies for problem prevention.
  14. Perform and lead risk assessment exercises in support of validation activities.
  15. Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ)

Requirements:

  • Requires a minimum of a 4-year degree in engineering, life sciences, or similar.
  • Requires 4-6 years increasing responsibility and experience in a medical device quality assurance environment.
  • Understanding of quality system regulations (ISO13485, 21CFR820)
  • Mechanically inclined
  • Knowledge of DOE, SPC, Gage R&R, and sampling plans
  • Six Sigma Certification a plus
  • ASQ Quality Engineer Certification a plus
  • Statistics and data analysis.


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