Jason Ecija
Manager, Design Quality @Hologic Formerly Gen-Probe
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WORK HISTORY
Manager, Design Quality @Hologic Formerly Gen-Probe
San Diego, CA, US
Hologic, San Diego, CAManager, Design Quality Engineering (2018 to Present)• Manage a team of quality engineers who support new product development and sustaining activities for diagnostic assays, instrument platforms, consumables, and software (system level and product specific).• Design control champion responsible for aligning the Quality Management System to applicable standards, regulations, and industry best practices.o 21 CFR part 820.30, ISO 13485, ISO 14971:2019, FDA Guidance, Cybersecurity, IEC 62304, IEC 62366• Design change owner for the duration of the product life cycle (development, sustaining, and obsolescence). Implemented processes for systemic tracking, managing, and timely implementation of all design changes.• Develop metrics to measure the effectiveness and impact of the design quality engineering team to the product development process, successful product transfers, launch, and post market surveillance. • Proactively audit design history files for completeness and accuracy prior to phase gate exits (definition and planning, development and verification, external clinical trial readiness review, validation and launch preparation, post launch surveillance) and product launches to ensure compliance with internal procedures and external standards and regulations. • Create and maintain policies, procedures, and business processes which govern product development and design changes. Confirm alignment with industry standards and best practices through periodic reviews, lessons learned, and audit feedback. • Oversee all aspects of the product development process such as design control, risk management, dFMEAs, pFMEAs, verification and validation, product/process transfer, engineering change controls, and design changes.• Develop and support all instrument sustaining activities such as returns, shipments, refurbishments, qualifications, installations, module changes, and upgrades.
EDUCATION
University of Washington
Certificate Program, Project Management
University of Phoenix
Master's degree, Business Administration and Management, General
UC San Diego
Certificate of Regulatory Affairs for Medical Devices, Regulatory Affairs
San Diego State University-California State University
Bachelor's of Science degree, Microbiology with emphasis in Public Health and Medical Technology
ABOUT JASON ECIJA
Seasoned Quality Professional with 25+ years of experience working in the Medical Device, Biotechnology and Diagnostics industries. Skilled in Quality and Design Assurance, Worldwide Product Development (US and ex-US), ISO-13485, ISO-14971, IEC 62304, IEC 62366, Assay/Software/Hardware Design, Verification and Validation (V&V), Sustaining, Risk Management, FDA/BSI/IVDR/MDSAP Audits, GLP/GMP. Bachelor\'s Degree in Microbiology emphasizing in Public Health and Medical Technology, Master\'s Degree in Business Administration and certifications focused in Project Management and Regulatory Affairs.
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