Evelyn Caranto

Company Overview: Specializing in innovative technologies for the development and manufacturing of nucleic acid-based therapies and vaccines.

Company Overview: Contractual Management Consulting.

• Expert ISO Guidance: Provided expert advice on ISO-series standards and best practices which resulted in 100% effective in ISO implementation.
• ISO Audits: Conducted comprehensive ISO-series audits and assessments and provided 100% on-time delivery of audit reports.
• Compliance Programs: Developed and implemented ISO-series compliance programs which aided organizations
• Training Delivery: Delivered training and workshops on ISO-series standards and requirements with average audience of 80 employees.
• Client Collaboration: Collaborated with clients to identify improvement opportunities in ISO-series compliance and ensured 100% successful audit

Company Overview: Medical Device Company of Powered Exoskeleton Suit.

• ISO 13485:2016 Compliance: Established a Quality Management System for product commercialization, ensuring compliance with ISO 13485:2016 and FDA's 21 CFR Part 820.
• Product Safety Certification: Successfully led the certification of the first exoskeleton suit prototype, achieving approval within 6 months of project initiation.
• Cross-Functional Collaboration: Developed project planning strategies that increased collaboration across functional teams, resulting in a 25% improvement in project timelines.
• Process Optimization: Created policies and procedures that reduced the design and development process cycle time by 20%.
• Test Plan Development: Co-established test plans and validation protocols for exoskeleton components, facilitating rapid approval from a third-party certification body within 6 weeks.
• Regulatory Liaison: Liaised with Health Canada and FDA officials to meet all product submission requirements, achieving compliance on the first submission attempt.
• Regulatory Expertise: Provided guidance on GCP and regulatory compliance across North America.
• Supplier Management: Established supplier management and onboarding requirements, ensuring 100% compliance with quality standards.
• Onboarding Training Analysis: Created a training needs analysis for new employees, enhancing onboarding efficiency and reducing ramp-up time by 40%.
• Technical Training Delivery: Delivered technical training on ISO 13485, ISO 62304, and FDA regulations to 100% of staff, ensuring comprehensive understanding of compliance requirements.
• Risk Management Leadership: Led risk management analysis for both software and hardware, improving risk mitigation strategies.

Company Overview: Design and manufacture of thermal imaging and machine vision cameras primarily used in defense and industrial sector.

SENIOR MANAGER, QUALITY ASSURANCE AND CUSTOMER EXPERIENCE 09/2012 to 01/2020
TELEDYNE/FLIR INTEGRATED IMAGING SOLUTIONS | Richmond, Canada
Company Overview: Design and manufacture of thermal imaging and machine vision cameras primarily used in defense and industrial sector.
• Leadership Role: Served as a member of the Management Team, directly reporting to the General Manager, and led the Quality Assurance, Compliance, and Customer Experience departments.
• Customer Loyalty Improvement: Fostered customer loyalty through high-quality interactions, resulting in a 25% increase in customer satisfaction scores.
• QA Team Management: Managed and led a large QA team across multiple locations in North America and enhanced QA practices.
• Product Quality Alignment: Aligned quality management with marketing strategies, increasing product feature releases and enhancements by 20%.
• Customer Feedback Analysis: Analyzed and presented monthly customer feedback and Net Promoter Score (NPS) to Top Management, driving strategic improvements.
• Enhanced Customer Experience: Conducted customer visits with Product Management and Sales, identifying strategic opportunities that increased brand awareness by 15%.
• CAPA Implementation: Established a closed-loop Non-Conformance Process (CAPA) and SCAR, improving cross-functional collaboration and reducing resolution time by 40%.
• Audit Dashboard Development: Developed an organizational dashboard for audit findings, promoting continuous improvement and reducing repeat issues by 30%.
• Regulatory Liaison: Liaised with notified bodies and auditors to ensure compliance, achieving a 100% success rate in product submission audits and certifications.
• WEEE Directive Compliance: Initiated the WEEE Directive compliance project, resulting in recognition as a Verdantix Innovation Awardee for exemplary environmental practices.
• Root Cause Analysis Leadership: Led root cause analysis of major customer complaints, resulting in a 50% reduction in complaint recurrence.
• Certification Transition: Successfully transitioned FLIR Richmond BC to ISO 9001:2015 certification with zero non-conformities.

Company Overview: Design and Manufacture of Portable Ultrasound Machine.

• Regulatory Submissions: Successfully submitted product regulatory filings and technical files for CE mark applications, FDA, and Health Canada, achieving 100% acceptance on first submissions.
• Point Person for Product Registrations: Served as the point person for product country registrations and FDA submissions, streamlining the registration process across multiple regions.
• Regulatory Liaison: Acted as the primary liaison with regulatory officials, facilitating efficient communication and coordination for product submissions across EU, North America, and Asia Pacific.
• Root Cause Analysis Leadership: Assisted in root cause analysis investigations, resulting in a 20% reduction in problem resolution time and enhancing team efficiency in problem-solving techniques.
• Document Control System: Established a robust document control management system compliant with ISO 13485, improving document retrieval efficiency by 40%.
• Quality Procedures Development: Developed quality procedures for new product introductions, reducing time-to-market by 25%.
• Internal Audits: Conducted internal audits for compliance with ISO 13485, FDA, and MDR regulations, achieving zero non-conformities.
• Equipment Maintenance: Ensured all calibration and preventive maintenance for equipment and instruments were conducted on schedule, improving operational reliability by 30%.
• QMS Compliance: Maintained compliance with the Quality Management System and other statutory regulations, ensuring uninterrupted product approval processes.

• QMS Leadership: Spearheaded the development and implementation of a robust, scalable Quality Management System in alignment with ISO 13485 and MDSAP, ensuring compliance across the full lifecycle of diagnostic products.
• Regulatory Compliance: Led audit readiness and execution, maintaining full compliance with global regulatory requirements, and facilitating successful external audits with zero major findings.
• Continuous Improvement: Championed process improvements across manufacturing and quality operations, reducing non-conformance trends and enhancing process efficiency by identifying and eliminating root causes improving 75% of operational efficiency.
• Cross-Functional Collaboration: Partnered closely with R&D, product development, and regulatory affairs teams to integrate quality into all phases of the design and development process, ensuring product reliability and regulatory success.
• Audit Oversight: Planned, directed and executed, internal and supplier audits, developed CAPA plans, and tracked resolution of quality issues to strengthen risk controls and supplier quality assurance.
• Training & Culture: Developed and delivered organization-wide training on quality ISO standards and procedures, promoting a culture of accountability and continuous improvement.
• Field Quality: Established field quality feedback loop for post-market diagnostics, reducing issue recurrence by 23%.

Company Overview: Design and Manufacture of optical sensors and systems.

• Quality Management System Support: Supported ISO 9001 protocols by establishing document procedures, enhancing operational compliance.
• Lean Six Sigma Implementation: Initiated Lean Six Sigma 5S and Statistical Process Control, improving operational efficiency by 60%.
• Established Cleanroom Procedures: Established cleanroom procedures, resulting in a 38% increase in production yield.
• Continuous Improvement Initiatives: Analyzed processes to drive continuous improvement, boosting overall productivity by 85%.

Company Overview: Design and Manufacturer of automotive float glass and fiber optics.

• Quality Management Leadership: Led a team to establish and implement a Quality Management System, Health and Safety program, and Environmental Compliance, achieving a 100% compliance rate.
• Product Technology Transfer: Successfully implemented product technology transfer across Asian subsidiaries, enhancing operational consistency.
• Production Expansion: Developed a workflow strategy that expanded the production line from 10 to 35, contributing to a 150% increase in revenue.
• Training Initiatives: Conducted training for Quality Engineers and Team Leads, resulting in a 30% increase in productivity and team motivation.
• ISO Certification Leadership: Led the organization to successful ISO 9001:1994 certification from 1998 to 2005, maintaining compliance throughout.
• QA Commercial Head: Appointed as QA Commercial Head, serving as the primary contact for all product specifications and inquiries.
• QA Commercial Leader Award: Awarded for outstanding negotiation in quality and pricing with critical suppliers, significantly enhancing supplier relationships.