Quality Assurance Engineer

6 days ago

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

Ryzen Solutions is seeking a highly skilled Quality Systems Engineer to support all Quality facets, including Auditing, Validation, Compliance handling, and Corrective Action Request processing in a 17025 Accredited Lab environment.

This role develops, prepares, presents, and implements solutions to issues and opportunities to help ensure the ongoing suitability and effectiveness of our Quality Management System (QMS).

Key Responsibilities
  • Manage and Support QMS Subsystems: Manage, support and maintain assigned QMS subsystems, including CAPA/CAR & Nonconformances, Change Controls and training, etc.
  • Facilitate Problem-Solving: Facilitate and drive effective problem-solving techniques that help resolve and prevent reoccurrence of QMS problems.
  • Develop and Deliver QMS Training: Develop, present and deliver QMS training content/programs in the Quality Management System.
  • Recommend Quality 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.
  • Perform Internal Audits: Manage and perform internal audits of assigned QMS elements to identify, present and report conformity to internal and external requirements (i.e., regulatory requirements, industry standards, corporate policies and operating procedures, methods and records).
  • Prepare and Present Audit Reports: Prepare and present clear audit reports which are supported by factual evidence of conditions found, meaningful conclusions and recommendations, and sound and unimpeachable judgment.
  • Manage the Internal Audit Schedule: Manage and support the preparation and issuance of the annual internal audit schedule including related documentation in accordance with internal audit policies and procedures.
  • Develop and Maintain Quality Procedures: Develop, present, release and maintain assigned quality system procedures which help to ensure compliance with QMS requirements and reduce/eliminate unnecessary operational burden.
  • Manage 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.
  • Business Travel: Some business travel might be occasionally required to support critical business needs.
Personal and Professional Attributes
  • Strong Business Acumen: Strong business acumen and functional linkage for effectiveness.
  • Customer Focus: High focus on customer service, and willing to go above and beyond to get the job done.
  • Leadership and Accountability: Drives leadership and accountability.
  • Collaboration: Work collaboratively with colleagues.
  • Strong Ethical Composition: Strong ethical composition.
  • Innovative Problem-Solving: Ability to find innovative solutions to complex problems.
Requirements for Eligibility
  • Education: Bachelor's degree (B.S.) in Packaging Technology, Quality, sciences or related field.
  • Experience: Minium of 3 years of experience operating in a testing lab with a robust Quality Management System; experience with device environment preferred.
  • Package Testing and Lab Experience: Prior package testing and lab experience are required.
  • ISO17025 Experience: Previous work experience in an ISO17025 environment is preferred.
  • Verification and Validation Techniques: Experience with Verification and Validation techniques (IQ,OQ,PQ) and methods is a plus.
  • Internal or Supplier Auditor: Previous internal or supplier auditor preferred.
  • Quality Performance Data: Experience with specifying, collecting, analyzing and presenting quality performance data.
  • Structured Problem-Solving Methodologies: Knowledgeable of structured problem-solving methodologies/techniques (i.e., Kepner-Tregoe, 8d, Shainin, 5 Why, DEMAIC, Kaizen, Lean Six Sigma) and quality tools (Cause and effect/Ishikawa-Fishbone, Control Charts, PDCA, Pareto Analysis, Check Sheet) is a plus.
  • QMS Training: Experience in supporting QMS Training programs.
  • MS Office Proficiency: MS Word, Excel, PowerPoint proficient, MS Access or similar relational database proficiency is preferred.
  • FDA and Agency Audits: Direct experience managing or participating in an FDA and other agency audits a plus.

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