Open to opportunities

Ali Zhian

@alizhian

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I improve medical device and digital health quality through supplier controls, risk management, compliance, and CAPA.

United States

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What I'm looking for

I'm looking to improve safe, compliant medical device or digital health products through supplier quality, software quality, risk management, CAPA, and cross-functional collaboration.

I've led supplier quality engineering for Boston Scientific's SFMD Endoscopy business, qualifying and validating supplier parts, reviewing first articles, approving IQ/OQ/PQ protocols, and auditing suppliers against FDA 21 CFR 820 and ISO 13485.

I investigate supplier issues through SCARs, 5-Why and Fishbone analysis, corrective-action verification, incoming quality controls, and FMEA updates. I also support post-market surveillance and field-complaint investigations to identify supplier-related product risks.

In SaMD and Digital Health, I oversaw software lifecycle activities aligned with IEC 62304, FDA guidance, and ISO 14971. I've reviewed sprint outputs, verification protocols, automated test scripts, hazard analyses, cybersecurity risk assessments, and traceability from user requirements through testing.

My earlier work at Merck, Abbott, and Squigl connected laboratory automation, medical device labeling, and SaaS product delivery. I translate scientific, regulatory, and operational workflows into requirements, UAT scripts, traceability matrices, change controls, and usable software solutions.

Experience

Work history, roles, and key accomplishments

Supplier Quality Engineer II

Boston Scientific

Jun 2023 - Aug 2026 (3 years 2 months)

Led supplier part qualifications and validations, reviewed First Article Inspection reports, and approved IQ/OQ/PQ protocols for outsourced parts. Managed SCARs, conducted audits, and ensured compliance with FDA 21 CFR 820 and ISO 13485.

Supplier Quality Engineering ISO 13485 21 CFR 820 SCAR First Article Inspection Quality Audits Root Cause Analysis Fishbone CAPA Post Market Surveillance Risk Management Supplier Management

Quality Engineer II - SaMD & Digital Health

Boston Scientific

Apr 2022 - Jun 2023 (1 year 2 months)

Oversaw software development lifecycle processes ensuring compliance with IEC 62304 and FDA guidance. Reviewed agile sprint outputs, user stories, and technical specifications to maintain regulatory audit readiness.

Software Quality Engineering EN 62304 Agile User Stories Test Protocols Traceability ISO 14971 CAPA

Senior Business Analyst - Lab Automation

Merck

Jul 2021 - Apr 2022 (9 months)

Managed external biotech software vendors and internal IT SLAs, drove system change controls, and minimized downtime for critical laboratory operations. Partnered with scientists to capture functional requirements and translated workflows into technical specifications.

Business Analysis Vendor Management SLA Management Change Control Requirements Gathering Technical Specifications Data Mapping Data Integrity GxP FDA 21 CFR Part 11 UAT Traceability

Business Analyst - Medical Device Labeling

Abbott

Feb 2019 - Jul 2021 (2 years 5 months)

Elicited and documented functional business requirements for enterprise labeling systems, translating global regulatory marking rules into software design specifications. Defined software logic for UDI, barcode structures, and serialization tracking.

Business Analysis Requirements Documentation UDI Serialization UAT Traceability FDA 21 CFR Part 11 EU MDR Supply Chain Workflow Optimization Change Control

Product Analyst - SaaS

Squigl

Feb 2016 - Feb 2019 (3 years)

Translated product visions for a video animation tool into detailed user stories, acceptance criteria, and wireframes. Owned and prioritized the product backlog in Jira, and liaised between local product leadership and offshore engineering teams.