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Quality Assurance Engineer

2 months ago

San Jose, California, United States Ryzen Solutions Full time
Job Description

We are seeking a highly skilled Quality Systems Engineer to join our team at Ryzen Solutions. As a Quality Systems Engineer, you will play a critical role in ensuring the ongoing suitability and effectiveness of our Quality Management System (QMS).

Key Responsibilities
  1. Manage and Maintain QMS Subsystems: Manage, support, and maintain assigned QMS subsystems, including CAPA/CAR & Nonconformances, Change Controls, and training.
  2. Facilitate Problem-Solving: Facilitate and drive effective problem-solving techniques to help resolve and prevent recurrence of QMS problems.
  3. Develop and Deliver QMS Training: Develop, present, and deliver QMS training content/programs in the Quality Management System.
  4. Recommend Quality System Enhancements: Recommend and implement enhancements to the quality system that result in improved corporate quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs.
  5. Perform Internal Audits: Manage and perform internal audits of assigned QMS elements to identify, present, and report conformity to internal and external requirements.
  6. Prepare and Present Audit Reports: Prepare and present clear audit reports supported by factual evidence of conditions found, meaningful conclusions, and recommendations.
  7. Manage the Internal Audit Schedule: Manage and support the preparation and issuance of the annual internal audit schedule, including related documentation.
  8. Develop and Maintain Quality System Procedures: Develop, present, release, and maintain assigned quality system procedures to ensure compliance with QMS requirements and reduce/eliminate unnecessary operational burden.
  9. Prepare and Present Quality Metrics: Manage and prepare and present assigned Quality metrics in support of operational needs, management review, and any other quality-driven data.
Requirements for Eligibility
  1. Bachelor's Degree in a Relevant Field: Bachelor's degree (B.S.) in Packaging Technology, Quality, sciences, or a related field.
  2. Minimum of 3 Years of Experience: Minimum of 3 years of experience operating in a testing lab with a robust Quality Management System; experience with device environment preferred.
  3. Prior Package Testing and Lab Experience: Prior package testing and lab experience are required.
  4. Previous Work Experience in an ISO17025 Environment: Previous work experience in an ISO17025 environment is preferred.
  5. Experience with Verification and Validation Techniques: Experience with Verification and Validation techniques (IQ, OQ, PQ) and methods is a plus.
  6. Previous Internal or Supplier Auditor: Previous internal or supplier auditor preferred.
  7. Experience with Quality Performance Data: Experience with specifying, collecting, analyzing, and presenting quality performance data.
  8. Knowledge of Structured Problem-Solving Methodologies: Knowledgeable of structured problem-solving methodologies/techniques (i.e., Kepner-Tregoe, 8d, Shainin, 5 Why, DMAIC, Kaizen, Lean Six Sigma) and quality tools (Cause and effect/Ishikawa-Fishbone, Control Charts, PDCA, Pareto Analysis, Check Sheet) is a plus.
  9. Proficiency in MS Office: MS Word, Excel, PowerPoint proficient, MS Access or similar relational database proficiency is preferred.
  10. Direct Experience Managing or Participating in FDA and Other Agency Audits: Direct experience managing or participating in an FDA and other agency audits a plus.