Quality Operations Engineer II

1 week ago

Austin, United States Saxon Global Full time
Summary
  • Advises company management on quality assurance requirements. Review non-conforming product along with product risk assessment and perform product failure investigations.
  • Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance.
Key Accountabilities
  • Participates in the nonconformance process to ensure timely completion of documentation stages.
  • Identifies, Reports and Monitors Nonconforming events for the areas of responsibility.
  • Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence.
  • Interacts with cross-functional teams to resolve quality issues.
  • Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
  • Develops Quality Instructions and Quality Standards.
  • Support in the development, validation and implementation of Test Methods.
  • Suggests, implements, reviews and approves engineering changes to support product life cycle.
  • 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.
  • Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities.
  • Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations.
  • Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
  • Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
  • Perform and lead risk assessment exercises in support of validation activities.
  • Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ)
Requirement
  • 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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