Quality Assurance Specialist
6 days ago
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:
- Participate in the nonconformance process to ensure timely completion of documentation stages.
- Identify, report, and monitor nonconforming events for the areas of responsibility.
- Perform product or process failure investigations and implement corrective and preventive actions to prevent reoccurrence.
- Interact with cross-functional teams to resolve quality issues.
- Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
- Develop Quality Instructions and Quality Standards.
- Support in the development, validation, and implementation of Test Methods.
- Suggest, implement, review, and approve 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)
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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