Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Ali Zhian

Winter Springs,FL

Summary

Supplier Quality Engineer with extensive experience in enhancing quality assurance processes in the medical device sector. Expert in conducting compliance audits and implementing corrective action plans to align with regulatory standards, resulting in improved supplier performance and reduced risk across supply chains. Demonstrated ability to lead initiatives that drive continuous improvement and uphold quality metrics.

Overview

1
1
Certification
11
11
years of professional experience

Work History

Supplier Quality Engineer

Boston Scientific
Remote
04.2022 - 08.2026
  • Conducted supplier audits to assess compliance with ISO 13485 and FDA QSR; collaborated on corrective action plans.
  • Managed risk assessments and health hazard analyses to ensure adherence to quality standards.
  • Coordinated supplier complaint investigations to ensure timely resolution and continuous improvement.

Quality Engineer

Boston Scientific
Remote
04.2022 - 06.2023
  • Led quality initiatives for software and digital health products, ensuring compliance with IEC 62304 and 82304 standards.
  • Facilitated collaboration between cross-functional teams to streamline development lifecycle and improve compliance.

Senior Business Analyst

Merck & Co.
Remote
08.2021 - 04.2022
  • Ensured quality and compliance for scientific data platforms, aligning systems with GxP and SOP requirements.
  • Collaborated with quality/compliance teams to uphold internal audit protocols and external standards.

Business Analyst

Abbott Laboratories
Minneapolis, US
02.2019 - 07.2021
  • Developed and validated IQ/OQ protocols for system changes, enhancing data traceability and process transparency.
  • Conducted root cause investigations for supply chain quality incidents to prevent future occurrences.

Product Analyst

Squigl
Minneapolis, US
02.2016 - 02.2019
  • Analyzed user feedback to enhance software features and improve user experience.
  • Collaborated with cross-functional teams to define product requirements and specifications.

Education

Bachelor of Science - Biology, Minor: Public Health

University of Minnesota – Twin Cities
Minneapolis, MN
12-2014

Skills

  • Quality assurance
  • Quality control planning
  • Process improvement
  • Supplier integration
  • ISO quality compliance
  • Validation protocols
  • Agile and Scrum frameworks
  • JIRA and Atlassian suite
  • Regulatory compliance
  • Risk assessment and mitigation
  • Document management systems
  • Quality assurance testing
  • Quality metrics reporting
  • Failure analysis methods
  • SAP and ERP systems
  • ServiceNow platform
  • Certification

    • ISO 13485 Lead Auditor

    Timeline

    Supplier Quality Engineer

    Boston Scientific
    04.2022 - 08.2026

    Quality Engineer

    Boston Scientific
    04.2022 - 06.2023

    Senior Business Analyst

    Merck & Co.
    08.2021 - 04.2022

    Business Analyst

    Abbott Laboratories
    02.2019 - 07.2021

    Product Analyst

    Squigl
    02.2016 - 02.2019

    Bachelor of Science - Biology, Minor: Public Health

    University of Minnesota – Twin Cities
    Ali Zhian