Josue Daniel Garcia Chavez

Quality Systems Leader with 11+ years of progressive experience in regulated manufacturing environments including Medical Devices, Aerospace, and Electronics. Strong expertise in ISO 13485, ISO/IEC 17025, AS9100, ISO 9001, and FDA 21 CFR Part 820 compliance frameworks. Experienced in leading cross-functional teams (12 direct reports) for testing and calibration laboratories, managing 6,000+ regulated measurement assets, and administering $200K USD annual operational budgets.

Proven record of strengthening QMS governance, improving CAPA effectiveness, supporting external certification audits, and delivering over $170K USD in validated cost savings through strategic internal calibration programs. Positioning toward Quality Systems leader roles with strong technical authority in metrology, validation, and measurement system governance.

Quality Systems Leader | ISO 13485 & ISO/IEC 17025 | Medical at Jabil - Healthcare Division (2022-09 – Present)

• Led ISO/IEC 17025:2017 accreditation initiatives ensuring technical competence and regulatory alignment for calibration and test laboratories.
• Oversaw calibration governance supporting ISO 13485 and FDA 21 CFR Part 820 compliance environments.
• Strengthened CAPA system effectiveness through structured root cause analysis and corrective action verification.
• Served as Lead Internal Trainer in Metrology and Quality Systems, developing technical competencies across engineering and technician teams.
• Executed Test Method Validations (TMV) and Gage R&R studies ensuring measurement system reliability.
• Participated in Management Review presenting KPIs including CAPA aging, audit findings, calibration compliance rate, and risk assessments.
• Supported external certification audits ensuring organizational readiness and timely closure of findings.

Lead Trainer – Metrology & Quality Systems (Part-Time / Concurrent Role) at Metrología CMC² (2020-02 – Present)

• Designed and implemented Quality Management Systems for laboratories of Test and Calibration aligned with ISO/IEC 17025 and ISO 9001.
• Led accreditation readiness projects for newly established laboratories.
• Developed Quality Manuals, SOPs, procedures, and technical documentation frameworks.
• Provided Trained technical personnel and engineers in calibration governance and regulatory compliance.
• Developed instructional advisory services in measurement management systems (ISO 10012).
• Delivered structured training programs in Metrology and ISO/IEC 17025 requirements.
• Developed instructional materials and technical workshops aligned with ISO 13485 and ISO 9001 frameworks.
• Strengthened organizational technical competency and audit readiness through targeted knowledge transfer.

Quality Engineer / Calibration Supervisor at Flex - Medical Division (Availmed) (2015-06 – 2020-02)

• Supervised 8-member technical team managing 5,000+ measurement assets in regulated manufacturing operations.
• Administered approximately $200K USD annual operational budget.
• Reduced external calibration expenses by 52%, generating $139K USD annual savings through internal capacity expansion.
• Closed 80+ internal non-conformities and achieved zero departmental complaints.
• Led internal audit preparation and supported external ISO 9001 & ISO/IEC 17025 certification audits.
• Managed CAPA investigations, supplier corrective actions (SCAR), and risk mitigation initiatives.
• Improved measurement governance aligning with ISO 13485 regulated environments.

Quality Test Laboratory / Calibration Engineer at TE Connectivity (2012-04 – 2015-06)

• Reduced external calibration budget by 68%, generating $35K–$40K USD savings through implementation of internal calibration systems.
• Implemented structured 8D problem-solving methodologies.
• Conducted validation studies and process capability analysis.
• Strengthened QMS compliance under ISO and regulated industry standards.
• Conducted quality laboratory tests: electrical, aging, tensile and compression, Environmental, mechanical and resistance, etc.

Industrial Electromechanical Engineer in Industrial Electromechanical Engineering – Universidad Tecnológica de Tijuana

Diploma in Industrial Metrology (170 hours) in Industrial Metrology – CIDESI Baja California

Facilitating on-site group training for human capital in Training and Development – CONOCER