Rick Fletcher Email & Phone Number

Portland, OR, US

Austin, Texas, US

Austin, Texas, US

FDA QA and compliance consultant for the medical device and IVD industry

Great startup company that I'm helping to prepare for certification to ISO 13485:2016.

Redwood City, CA, US

World’s Leading Provider of Genomic-Based Tests for Personalizing Cancer CareOur Mission: To transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics and services for patients.Our Vision: To revolutionize the treatment of cancer throughout the patient journey.Genomic Health is the world's leading provider of.

Waltham, MA, US

Managed GMP support activities for the Life Technologies group of Thermo Fisher Scientific. Performed QS audits at GMP sites providing feedback to local and global management. Worked with local QA teams to address findings from FDA audits. Provided updates to global management on progress.Managed QA teams at multiple business locations. Worked with local.

Sunnyvale, CA, US

• Prepared Quality sections for regulatory submissions (510k, Canada, CE); reviewed regulatory submissions providing feedback to Regulatory Affairs department
• Provided responses to US FDA regarding submissions
• Reviewed Regulatory Affairs policies and procedures as needed
• Primary contact with the U.S. Food and Drug Administration for compliance activities including inspections, product recalls, and MDRs
• Member of the corporate strategic planning executive team
• Spearheaded quality system continuous improvement projects for Cepheid’s domestic and foreign manufacturing facilities

Irvine, California, US

• Provided and reviewed Quality sections for regulatory submissions (PMA, Canada, CE)
• Facilitated the implementation of quality processes and systems including corporate wide software upgrades and tools
• Facilitated quality system training events and activities for company-wide operations
• Managed interactions with the U.S. Food and Drug Administration and ISO auditors (inspections, recalls, MDRs)
• Ensured compliance with corporate quality systems and procedures that included document control, customer complaint records, internal and external audit programs, product vigilance reporting, validation of business.

US

• Provided Manufacturing section of Modular PMA submission for BLN assay; provided responses to Regulatory Affairs regarding questions from FDA on submission
• Played a central role in a GeneSearch Breast Lymph Node project and PMA submission ensuring validation lots and IUO clinical trial lots were manufactured per timeline requirements; coordinated manufacturing activities.
• Spearheaded the successful move of manufacturing and quality control operations to a new facility
• Identified key sources of variability for GeneSearch products working with the research and development groups and assisted external suppliers with the integration of new quality control policies and procedures to.
• Revised operational site manufacturing and quality control policies and procedures; identified, audited and negotiated supply and service agreements with key suppliers of critical raw materials and external quality.
• Streamlined commercial product and development operations and cross-trained scientists to integrate Cellsearch and Genesearch quality control departments into a single team

Managed quality systems for the North American DNA sequencing and life science research reagent manufacturing operations. Led manufacturing management and audit steering committee teams ensuring sites maintained ISO certification in addition to standardizing quality policies and procedures across global manufacturing facilities.

CA, 92121, US