Quality Strategy Lead — FDA/ISO Compliance & CI

ITG Brands; Cayey (PR); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Dollar-for-dollar 401k match up to 3%

15 days of vacation

Employee recognition programs

Educational assistance

Occupational clinic

Weekly payroll

Stock savings plan

Health insurance

Life insurance

Vision insurance

Job summary

ITG Brands seeks a Quality Lead to provide strategic direction and oversee the Quality function, ensuring compliance with FDA, ISO and corporate standards. This senior role drives continuous improvement and strengthens quality systems across manufacturing and product quality.

You will lead QA strategy, CAPA, audits, and QMS improvements, partner with Product Development, Engineering and Operations, and serve as primary Quality representative during FDA inspections.

Qualifications

• Bachelor’s degree in Science (Chemistry, Biology) and/or Engineering; master’s degree preferred.
• 5–7 years in FDA-regulated manufacturing with leadership experience.
• Strong expertise in CAPA systems, ISO 9001:2015, Quality Management Systems (QMS) and continuous improvement.
• Bilingual in English and Spanish.

Responsibilities

• Establish and drive the Quality strategy aligned with FDA regulations, ISO standards, corporate policies, and the PQRS program.
• Oversee resource planning, staffing, and prioritization of departmental activities to meet operational and quality objectives.
• Lead preparation and follow-up for FDA inspections and regulatory interactions; act as primary Quality representative.
• Review and analyze quality KPIs; drive data-based decisions and continuous improvement initiatives.
• Ensure effective execution and continuous improvement of PQRS, including defect reduction and data integrity.
• Partner with Product Development, Engineering, and Operations to define and optimize product specs and processes.
• Lead and approve CAPA for root cause analysis and sustainable solutions.
• Drive FDA readiness programs and sustained audit compliance.

Skills

Leadership

CAPA management

ISO 9001:2015

QMS

Data analysis

Cross-functional collaboration

MS Office 365

Bilingual English and Spanish

Education

Bachelor's degree in Science or Engineering

Master's degree preferred

Tools

SAP

TrackWise

MiniTab

JMP

Quality management software

Job description

ITG Brands seeks a Quality Lead to provide strategic direction and oversee the Quality function, ensuring compliance with FDA, ISO and corporate standards. This senior role drives continuous improvement and strengthens quality systems across manufacturing and product quality.

You will lead QA strategy, CAPA, audits, and QMS improvements, partner with Product Development, Engineering and Operations, and serve as primary Quality representative during FDA inspections.