Dean S.
Special Quality Project Engineer @Pro-Dex, Inc.
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WORK HISTORY
Special Quality Project Engineer @Pro-Dex, Inc.
Tustin, CA, US
Lead the SICR and PPAP processes, ensuring seamless execution and approval for all supplier changes, impacting suppliers and customers.• Partner with R&D and NPD on CTQs, PPAP deliverables, risk documentation, and quality planning.• Develop Master Process Control Plan, validation protocols (IQ/OQ/PQ), and inspection procedures aligned with ISO 13485.• Conduct and support clean room validation ahead of third-party audits.• Collaborate with suppliers on audits, qualifications, SCAR management, and QMS alignment.• Lead statistical analysis and process control implementation using software and manual systems.
EDUCATION
Fullerton College
Associate of Science (A.S.), General Studies
Southern California Institute of Technology
Bachelor’s Degree, Biomedical Medical Engineering
ABOUT DEAN S.
Hands-on Quality leader with nearly a decade of medical device industry experience, consistently operating at a managerial level across supplier management, CAPA remediation, risk analysis, and QMS compliance. Proven success in leading cross-functional initiatives, authoring ISO 13485-compliant SOPs, executing clean room validations, and resolving systemic quality issues. Known for a pragmatic, “trust but verify” approach, cross-departmental communication, and building sustainable compliance frameworks. Looking to bring strategic leadership to a Senior Quality Engineer or Quality Manager role.
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