Diana N. Bakchajian
Sr Staff Global Quality Audits & Compliance Specialist @Illumina
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WORK HISTORY
Sr Staff Global Quality Audits & Compliance Specialist @Illumina
San Diego, CA, US
Supervise junior auditors and provides quality systems leadership, oversight, andstrategic guidance to drive global compliance audits and develop/improve processesand procedures Lead Global internal quality system audit program, may include travel to other sites Partner with global site leads to optimize the quality audit program to meet 6+regulatory regions (US, EU, Canada, Australia, Brazil, Japan, etc.) Enable MDSAP and/or IVDR transition and support ILMN geographical expansions Identify, assess, resolve, and where needed, escalate potential complianceand/or product quality risks Ensure audit findings and risks are clearly communicated; and corrections and CAPAsare appropriate to risk level Trend + analyze global audit data and report on analysis, make recommendations,and drive program to improve products and processes Resolve complex non-compliant issues by the most efficient and effective methods Carry out quality system due diligence and integration activities as required by thebusiness Lead and engage in foundational quality appraisals and improvement related toVoluntary Improvement Program Advise and consult on project/quality plans, risk assessments and remediation plans Identify, design, and deliver training programs to drive a quality culture + develop auditors Manage internal and third-party [FDA, Notified Body, Customer] quality system auditactivities (schedule, plan, perform, CAPA follow up)
EDUCATION
Northeastern University
Master of Science - MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices
UC San Diego
Bachelor of Science - BS, Human Biology
SKILLS
ABOUT DIANA N. BAKCHAJIAN
CQA, CMDA, CQIA, and ISO 13485:2016 Lead Auditor Certified with extensive experience in Medical Device, Pharmaceuticals and Biologics.I hold a Master of Science in Regulatory Affairs with a specialization in Medical Devices, Pharmaceuticals, and Biologics. My background includes extensive hands-on experience auditing quality management systems across clinical operations, manufacturing sites, and laboratories to ensure sustained compliance with international standards and regulatory frameworks.My expertise includes ensuring compliance with global regulations and standards, including but not limited to: ISO 13485, ISO 14971, ISO 62304, IEC 81•••51, CMDR SOR/98-282, TG(MD)R, MHLW MO 169, IVDR 2017/746, RDC ANVISA 665/2022, and U.S. FDA 21 CFR Parts 820, 11, 210, 211, 600, and 606. I am recognized for translating complex regulatory requirements into practical, scalable quality system solutions that support both compliance and business objectives.I have successfully led enterprise-wide IVDR 2017/746 QMS transitions, including the implementation of UDI requirements. I have also driven inspection readiness initiatives by training and managing front- and back-room teams in support of regulatory authority and Notified Body inspections. My experience includes managing FDA 483 responses, corrective action strategies, and 483 response follow-up to ensure timely and effective resolution.
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