Quality Operations Engineer II

3 weeks 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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