Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Devin Fierro

Waianae

Summary

Quality Assurance professional with over ten years of experience in developing and maintaining Quality Management Systems. Demonstrated ability to enhance operational efficiency through analytical problem-solving and effective conflict resolution. Skilled in process improvement, compliance management, and risk assessment, ensuring high product quality and customer satisfaction. Committed to driving team success and achieving operational excellence.

Overview

11
11
years of professional experience

Work History

HEAD OF REGULATORY

TITIN KM BIOMEDICAL
Bozeman
03.2024 - 06.2025
  • Accomplished Regulatory Manager with extensive experience leading regulatory affairs in the medical device industry, ensuring compliance with international regulations, and supporting successful product development and commercialization.
  • Demonstrates a comprehensive understanding of the FDA, EU MDR, ISO 13485, and other global regulatory frameworks. Adept at developing regulatory strategies that align with business goals, preparing and submitting high-quality regulatory submissions (510(k), PMA, CE marking), and managing interactions with regulatory authorities.
  • Effectively leads cross-functional teams in the creation and maintenance of technical documentation, risk assessments, and labeling to support global market access.
  • Proven track record in facilitating regulatory approvals and product registrations in diverse markets, including North America, Europe, Asia-Pacific, and Latin America.
  • Skilled in monitoring regulatory changes and proactively advising internal stakeholders to mitigate compliance risks.
  • Recognized for strong leadership in audits and inspections, regulatory due diligence during mergers and acquisitions, and post-market surveillance activities.
  • Passionate about driving quality and patient safety while enabling innovation through clear, compliant, and strategic regulatory oversight.
  • Managed ISO 13485/9001 certification efforts. Ensured the Quality Management System was suitable, effective, and compliant.

QUALITY ASSURANCE MANAGER

ONDINE BIOMEDICAL
Bothell
11.2022 - 08.2023
  • Managed CAPA program, including root cause analysis, plans, verification, and closure.
  • Conducted internal audits of processes, products, and systems to ensure compliance with quality standards.
  • Oversaw complaint program, conducting thorough investigations on reported issues.
  • Investigated customer feedback and developed strategies for addressing complaints quickly and efficiently.
  • Developed personnel within QA department to enhance team capabilities.
  • Conducted data analysis to prepare metrics aligned with quality objectives.
  • Supported internal and external audits, ensuring compliance with regulations.
  • Performed change analysis for quality system and product documentation release.
  • Reviewed SOPs, work instructions, and forms, providing revision recommendations.
  • Contributed to new product development by offering design assurance input.

QUALITY ASSURANCE LEAD

NANOSTRING TECHNOLOGIES
09.2018 - 11.2022
  • Collaborates with Quality Engineering and other departmental stakeholders to initiate new Corrective and Preventative Actions (CAPA).
  • Identifies and assigns CAPAs while constructing a closure plan.
  • Assigns action items to stakeholders, quality investigators, subject matter experts, and ensures completion of tracked items.
  • Reviews updated procedures and training records to ensure compliance.
  • Maintains the CAPA workflow within MasterControl and provides metrics to senior leadership.
  • Track step due dates and collaborates with owners to complete required actions in a timely manner.
  • Performs audits and trend analysis to verify effectivity of corrective actions.
  • Teams with Supplier Quality Engineers to document Supplier Corrective Action Reports (SCAR) within MasterControl.
  • Responsible for improving NanoString’s process for complaint handling and investigations.
  • Conducted a retrospective review of one thousand diagnostic complaints for remediation efforts to mitigate potential audit findings.
  • Creates and presents monthly metrics for Operational Excellence and Customer Experience teams.
  • Performed reviews of devices and applicable documentation to ensure country-specific requirements are met.
  • Assisted in developing a more effective tracking process for items needing review.
  • Responded to urgent requests from country representatives to provide supporting documentation for currently marketed devices.
  • Teamed with Corporate and International Regulatory staffs to provide support for new products and changes to existing products.
  • Collected data on device labels and implemented a more effective storage strategy to assist in identifying requested information.
  • Provides guidance to PMA and product registration procedures. Prepares device submissions.

QUALITY SPECIALIST III

PHILIPS MEDICAL - ECRA
08.2016 - 11.2017
  • Appointed Team Lead for Emergency Care and Resuscitation to lead 12 FTEs and Contractors
  • The first point of contact for post-market surveillance inquiries supporting teams worldwide.
  • Worked directly with 2 of the largest US customers (Fire Department of NYC and Pinellas County EMS) to better handle their service needs while also managing our service records.
  • Participated in onsite customer meetings to provide input from Quality Assurance to minimize device downtime and maximize first contact efforts.
  • Triaged and escalated Service Records to verify true complaints and review for Death and Serious Injuries.
  • Performed thorough failure investigations and documented all findings with TrackWise system.
  • Collaborated with Failure Analysis and Repair Centers to identify trends.
  • Contributed to Complaint Handling process improvement during the internal transition.
  • Interviewed, hired, and trained new employees and contractors to support the Quality Department transfer from Andover, MA to Bothell, WA.
  • Provided personnel metrics and KPI reports to senior leadership on a weekly basis.

TECHNICAL SUPPORT REPRESENTATIVE/QUALITY ASSOCIATE

FUJIFILM SONOSITE
07.2015 - 08.2016
  • Originated a cross-functional weekly team meeting to identify trends and to better understand common failures.
  • Converged with Engineering teams to discuss critical failures. Summarized all findings and sent a report to the Technical Support team to better equip them for failure analysis during customer interactions
  • Assisted with improving the design and templates of Customer Service Agreements to maximize time spent in preparing customer service requests. (Impacted Representative Ready Times)
  • Contributed to the implementation of Oracle redesign to better capture important data and ensured consistent and valuable data.
  • Initiated changes to ticket creation and common verbiage to better capture failure modes and assist Quality Assurance / Regulatory Affairs in identifying beneficial data.
  • Trained team members on the importance of captured data as the first line of communication between customers. (Reduced duplicated ticket creation and improved customer satisfaction)
  • Provided training on patient use cases and device failures to assist with Quality monitoring.

QUALITY COMPLAINTS TECHNICIAN

SPACELABS HEALTHCARE
04.2014 - 06.2015
  • Lead Retrospective Review Project (over 10,000 Complaint Records, Service Records, DHRs, Sales Orders).
  • Effectively managed several contractors and provided clear instructions to accomplish tasks.
  • Set goals and timelines for the review project and provided updates biweekly to senior leadership.
  • Through effective management completed the Retrospective Review Project 4 months ahead of schedule which saved on resources and allowed more time for audit preparations.
  • Organized collaborations between Regulatory Affairs, Quality Assurance, Global Product Support, Field Service, and Equipment Repair Center to better document service records and ensure consistency.
  • Contributed to improving the Complaint Handling Work Instructions and Quality Procedures by identifying outdated sections and revising current procedures for clarity.
  • Organized and cataloged Sales Order Inventory and Device History Records (DHRs) physically onsite to better manage records.
  • Created Digital Records and backups of all physical data for online review to be accessible online to improve time management and assist with audit preparations

Education

ISO 13485:2016 Lead Auditor (TPECS) -

BSI
12.2019

Bachelor of Science - Information Technology, Networking

University of Phoenix
06.2015

Skills

  • Self-motivated and detail-oriented
  • Process implementation
  • Risk management analysis
  • Workflow optimization
  • Quality assurance
  • Regulatory compliance
  • Gap analysis
  • Intermediate Microsoft Office skills
  • Analytical problem solving
  • Goal-oriented mindset
  • Fast-paced environment performance
  • Product failure investigations
  • FDA audit experience
  • ISO 13485 and 14971 familiarity
  • Electronic quality management systems expertise
  • Change management
  • Internal auditing
  • Customer service
  • Data analysis
  • Project management
  • Medical device regulations
  • ISO standards
  • Product lifecycle management
  • Labeling compliance
  • Post-market surveillance
  • Document management
  • Continuous improvement
  • Cross-functional collaboration
  • Leadership development
  • Personnel training

References

References available upon request.

Timeline

HEAD OF REGULATORY

TITIN KM BIOMEDICAL
03.2024 - 06.2025

QUALITY ASSURANCE MANAGER

ONDINE BIOMEDICAL
11.2022 - 08.2023

QUALITY ASSURANCE LEAD

NANOSTRING TECHNOLOGIES
09.2018 - 11.2022

QUALITY SPECIALIST III

PHILIPS MEDICAL - ECRA
08.2016 - 11.2017

TECHNICAL SUPPORT REPRESENTATIVE/QUALITY ASSOCIATE

FUJIFILM SONOSITE
07.2015 - 08.2016

QUALITY COMPLAINTS TECHNICIAN

SPACELABS HEALTHCARE
04.2014 - 06.2015

ISO 13485:2016 Lead Auditor (TPECS) -

BSI

Bachelor of Science - Information Technology, Networking

University of Phoenix

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