Open to opportunities

sean cole

@seancole

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Adaptable Quality Assurance Analyst with strong analytical skills.

United States

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What I'm looking for

I am seeking a role that values quality and compliance, offering opportunities for growth and collaboration.

I am an adaptable and self-motivated Quality Assurance Analyst with a proven track record of thriving in fast-paced environments. My strong analytical skills enable me to manage multiple projects simultaneously while maintaining a focus on quality and compliance. With a background as an honorably discharged veteran holding a US Government Secret Clearance, I bring a unique perspective to my work, emphasizing accountability and effective communication.

Throughout my career, I have successfully supported various organizations, including Philips and Thermo Fisher, in their quality assurance and post-market surveillance efforts. My experience includes collaborating with cross-functional teams to ensure compliance with regulatory standards, conducting thorough investigations, and implementing corrective actions to enhance product quality. I take pride in my ability to drive efficiency and improve customer experiences through proactive problem-solving and effective stakeholder engagement.

Experience

Work history, roles, and key accomplishments

Current

Quality Specialist III, Corrections and Removals

Current

Philips

Jul 2021 - Present (4 years)

Supported the field action process, customer and regulatory notifications, and product correction or removal. Assisted with the preparation of customer letters, field action status reports, and communications to regulatory agencies.

Field Action Process Product Correction Documentation Risk Assessment

Quality Specialist III

Thermo Fisher

Oct 2021 - Nov 2022 (1 year 1 month)

Collaborated with operations, service, support, and customer service to triage and escalate Amplitude installations and post-market support. Drove accountability with cross-functional roles across a matrixed organization and managed daily complaint assessments.

Cross Functional Collaboration Customer Service Dashboards Process Improvement Problem Solving Escalation Management

Complaint Specialist II

Becton Dickinson (BD)

Aug 2020 - Jun 2021 (10 months)

Identified complaints for closure, ensuring correct documentation in Trackwise and verifying investigation reports. Responsible for medical device post-market surveillance and complaint handling functions for the US and Canada.

Quality Assurance Complaint Handling Trackwise Investigation Health Canada Regulations Documentation Regulatory Compliance

Product Surveillance

Allergan

Oct 2019 - May 2020 (7 months)

Initiated and conducted initial investigations for complaint files, following complaint handling regulations and internal procedures. Maintained and updated databases with all complaint activity and coordinated with various departmental customers.

Database Management Regulatory Compliance Quality Assurance Customer Care

Quality Assurance Specialist II

Dexcom

Mar 2016 - Aug 2019 (3 years 5 months)

Processed and investigated complaints per 21 CFR Part 820 and Standard Operating Procedures (SOP). Evaluated complaints to determine if Medical Device Reporting (MDR) was necessary and submitted MedWatch reports.

Quality Assurance 21 CFR 820 SOP流程设计 MedWatch Reports ISO 13485 Root Cause Analysis

Education

Degrees, certifications, and relevant coursework

California College San Diego

Bachelor of Business Administration, Business Administration

Grade: Dean’s List

Activities and societies: Dean’s List, Perfect Attendance

Achieved Dean's List recognition and maintained perfect attendance throughout the program. Focused on core business principles and administrative practices.