Cypress HCM ยท 4 days ago
Quality Engineering Technician
Cypress HCM is seeking a Quality Engineering Technician to lead hands-on quality engineering activities in the medical device sector. This role involves executing validation, testing, statistical analysis, and quality system activities to ensure compliance with ISO 13485 and FDA requirements.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Author, review, and execute validation protocols, test methods, and technical reports
Lead verification, validation, and measurement system analysis (Gage R&R, capability studies, DOE)
Perform statistical analysis to identify trends, risks, and process improvement opportunities
Support root cause analysis and CAPA activities for product and process issues
Partner cross-functionally with Design, Manufacturing, and Quality Engineering teams
Maintain accurate documentation and records within the electronic QMS
Support continuous improvement initiatives across development and manufacturing
Qualification
Required
Associate or Technical degree with 10+ years of medical device quality experience
Strong knowledge of ISO 13485, FDA QSR, validation, and design/manufacturing controls
Advanced experience with statistical tools (Minitab, SPC, Gage R&R, DOE)
Proven ability to author and approve quality protocols and reports
Background in electronics manufacturing and test methods
Strong analytical, organizational, and problem-solving skills
Excellent written and verbal communication abilities