Summary
Overview
Work History
Education
Skills
Certification
Timeline
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Brian Morrison

Minnesota

Summary

Results oriented professional with experience in quality investigation, supplier management, and regulatory compliance within the medical device industry. Proven track record of identifying root causes of quality issues, implementing corrective actions (CAPA), and collaborating with suppliers to ensure consistent product quality. Demonstrated expertise in design transfer, patent search, and TAA compliance for U.S. government contracts. Adept at developing clear inspection plans, conducting joint inspections with suppliers, and maintaining regulatory documentation to ensure compliance with ISO 13485, ISO 9001, and FDA standards. Seeking to leverage these skills in a challenging role.

Overview

1
1
year of professional experience
1
1
Certification

Work History

Associate Product Manager

RonexMed (MedSource Labs Extension)
09.2024 - Current
  • Quality Control and Risk Management: Conducted hands-on inspections of , verifying material consistency and performance through effective verification and validation test plans to ensure user needs and customer requirements are met.
  • Supplier Corrective Action and CAPA Implementation: Investigated recurring quality issues products and collaborated with suppliers/manufactures to identify and correct root causes.
  • Mitigated manufacturing errors by developing clear and detailed inspection plans for suppliers to follow after production, ensuring product quality and compliance with specifications.
  • Supplier Compliance and ISO Audits: Verified supplier documentation for compliance with quality standards, including ISO and FDA requirements.
  • Conducted joint inspections with suppliers during root cause analysis, identifying and resolving material defects at the source.
  • Reduced product rejection rates by 20% through clear, easy-to-follow quality standards.
  • Conducted compliance reviews to confirm that all sourced products adhered the country of origin requirements by obtaining COO's

Associate Product Manager

Medsource Labs
06.2024 - Current
  • Used Quality Investigation and Corrective Action Plans to analyze customer complaints and product quality concerns, identifying root causes and implementing corrective actions.
  • Achieved a 40% reduction in product defects by working directly with the supplier to improve manufacturing techniques.
  • Enhanced product consistency by resolving absorbency variability in non-woven aborbent pads through supplier adjustments.
  • Supplier Quality Management: Conducted supplier evaluations, established clear quality expectations, and maintained supplier performance records.
  • Reduced supplier defect rates by 30% through proactive communication and corrective action tracking.
  • Negotiated with suppliers to improve quality without increasing costs, ensuring consistent product standards.
  • Cost Analysis and Sourcing: Conducted detailed cost analysis for OR towels and body bags, assessing supplier quotes and calculating total landed costs, including tariffs (USMCA analysis).
  • Secured a 10% cost reduction on products by negotiating better pricing without sacrificing quality.
  • Product Development and Design Transfer: Managed design transfer activities, maintaining and updating design documentation (DMR, DHF), and verifying that design changes were implemented accurately.
  • Facilitated design transfer of APLS body bags, ensuring design specifications were consistently met.
  • Regulatory Compliance and ISO Audits: Organized and reviewed regulatory documents, including ISO certifications, Proposition 65 compliance, and supplier Certificates of Compliance.
  • Patent Search and Freedom-to-Operate Analysis: Conducted comprehensive patent searches to assess the intellectual property landscape for new product designs, ensuring freedom to operate.
  • Identified potential patent conflicts for a new wound care product, providing insights for design adjustments.
  • TAA Compliance and Risk Management: Verified supplier certifications and documented the country of origin for components used in products for U.S. military contracts, ensuring compliance with TAA requirements.
  • Conducted risk assessments on supplier compliance, maintaining TAA eligibility for U.S. government contracts.
  • Cross-Functional Collaboration: Coordinated with engineering, regulatory, and manufacturing teams to ensure product designs met quality and compliance standards.
  • Resolved design discrepancies in products BOM and design drawings through effective cross-functional communication.
  • Process Documentation and Training: Developed SOPs for quality control processes, trained staff on compliance, and using EQMS system to ensure well maintained clear quality records.
  • Delivered targeted training on TAA compliance, ensuring staff understood compliant materials for U.S. military contracts.

Education

Bachelor of Science - Computer Engineering Technology

Minnesota State University
Mankato, MN

Skills

  • Quality Management Systems (ISO 13485, ISO 9001, FDA 21 CFR Part 820)
  • Corrective Action Plans (CAPA) and Risk Management
  • Patent Search and Freedom-to-Operate Analysis
  • Design Documentation (DMR, DHF, Compliance)
  • Regulatory Compliance (ISO Audits, FDA, TAA)
  • Root Cause Analysis (Identifying Trends, Problem Resolution)
  • Supplier Quality Management (Performance Tracking, Quality Improvement)
  • Microsoft Office Suite (Excel, Word, PowerPoint)
  • SolidWorks (Basic Proficiency)

Certification

  • Professional Scrum Master 1 - Scrum.org
  • TAA Compliance Certification - Centre Law
  • ISO 13485 Quality Management Systems - Experience-Based Proficiency
  • ASQ ISO 9001:2015 Lead Auditor Certification - In Progress

Timeline

Associate Product Manager

RonexMed (MedSource Labs Extension)
09.2024 - Current

Associate Product Manager

Medsource Labs
06.2024 - Current

Bachelor of Science - Computer Engineering Technology

Minnesota State University

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Brian Morrison