Silva Krikorian

About Silva Krikorian

Experienced Quality Assurance professional within the pharmaceutical,medical device and electronic manufacturing companies. Experience in quality control, research and manufacturing. Strong skills in auditing in an FDA regulated environment. Highly accomplished, dedicated and disciplined professional seeking to contribute to and grow with a dynamic, progressive and innovative organization. Recognized team player and performer, consistently completing assignments on time and under budget. A troubleshooter able to effectively and efficiently resolve issues and meet and achieve challenging goals and objectives. Over 10 years of expertise in wet chemistry, and other analytical activities at research pharmaceutical companies. Excellent communicator particularly with chemists and engineers. Ability to construct clear concise documentation for non-technical, scientific and regulatory audience. Self starting professional with a natural interest in learning, solving problems and helping people.

Experience

1. Quality Assurance Specialist Ii

   Aerin Medical

   May 2023 — Present · Mountain View, CA, US

   Managed and processed all Document Change Orders (manual and via Box) in compliance with ISO13485 and company procedures.Transitioned 100% of controlled documentation to new QMS platform (Simploud); supported change control improvements and initiated procedural revisions.Enhanced training workflow by implementing Adobe Sign, improving compliance and efficiency; developed training materials and let onboarding sessions for new hires.Maintained and updated Document Change Order (DCO) log, DCO Number log and Training Ma- trix, ensuring for accuracy for internal and external audits.Collaborated with document originators to resolve DCO issues and ensure timely approvals. Prepared new hire documentation, assigned and managed training, and maintained compliancerecord for employee status changes.Update the Training Matrix and follow up end of year with Training Effectiveness updates from thedepartments affected.Improved BOX filing system structure for easier retrieval and reduced redundancy.Issued Acknowledgement letters and maintained distribution lists for Contract Manufacturer.Updated Device Master Records (DMR) with approved DCO revisions.Supports initial product complaint in-take in Simploud.Support and recommend change control process improvements including initiating proceduralrevisions.Supported FDA and BSI audit readiness by maintaining complete, audit-ready documentationand logs.Oversaw pest control documentation and monthly reporting.Assisted with quality activities including NCRs, scrap/return to stock disposition (NetSuite), andinitial product complaint intake in Simploud. Delivered Adobe Sign training for DCO originators and approvers; launched refresher sessionsand developed onboarding materials to improve compliance and process efficiency.Supported FDA and BSI 2025 audit readiness by preparing and organizing required documenta-tion in alignment with regulatory standards.

Education

• California State University, Los Angeles

  Bachelor of Science - BS, Clinical Laboratory Science/Medical Technology/Technologist

  1994 — 1996

• Glendale Community College

  Clinical Laboratory Science/Medical Technology/Technologist

  1992 — 1994