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Job Requirements of Quality Operations Engineer II:
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Employment Type:
Full-Time
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Location:
Austin, TX (Onsite)
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Quality Operations Engineer II
- 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.
Recommended Skills
- Administration
- Auditing
- Corrective And Preventive Action (Capa)
- Data Analysis
- Product Lifecycle
- Quality Engineer Certification
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Job ID: NDYxNzoxNzkwOTc3MDAw
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