Quality Lead

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

We are seeking for a Quality Lead will provide strategic direction and oversight to the Quality function, ensuring full compliance with company objectives, policies, and regulatory standards (FDA, ISO, and Corporate Central Quality). This role operates at a higher leadership level than the Quality Supervisor, driving continuous improvement, strengthening quality systems, and partnering cross-functionally to enhance overall manufacturing performance and product quality.

Duties

• 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.
• Provide governance and oversight for new process implementations and machinery Quality Acceptance Tests (QAT), including Zero Production (ZP) acceptance protocols.
• Act as primary Quality representative during FDA inspections, audits, and regulatory interactions; lead preparation, execution, and follow-up activities.
• Review and analyze quality performance metrics (KPIs), driving data-based decisions and continuous improvement initiatives.
• Ensure effective execution and continuous improvement of the Product Quality Rating System (PQRS), including defect reduction strategies and data integrity.
• Partner with Product Development, Engineering, and Operations to define, validate, and optimize product specifications and manufacturing processes.
• Lead and approve Corrective and Preventive Actions (CAPA), ensuring root cause analysis effectiveness and sustainable solutions.
• Drive FDA readiness programs and ensure sustained audit compliance across operations.
• Champion continuous improvement initiatives, including FOCUS 5 and other operational excellence programs.
• Define and implement systems to ensure accuracy and reliability of testing, measuring, and analytical equipment.
• Oversee Quality Improvement Plans and ensure timely completion of actions.
• Strengthen quality culture by promoting accountability, training, and adherence to self-inspection standards across production teams.
• Ensure robust documentation practices, including SOPs, Work Instructions, and quality records, in compliance with QMS requirements.

Skills

• Bachelor’s degree in Science (Chemistry, Biology) and/or Engineering (Master’s degree preferred).
• Minimum of 5–7 years of experience in an FDA-regulated manufacturing environment, including leadership experience managing teams.
• Strong expertise in CAPA systems, ISO 9001:2015, Quality Management Systems (QMS), TPMO, and continuous improvement methodologies.
• Proven experience leading cross-functional projects and driving organizational change.
• Advanced proficiency in MS Office 365 (Word, Excel, PowerPoint, Teams, Outlook).
• Experience with quality systems and tools such as SAP, TrackWise, MiniTab, JMP, and/or other statistical analysis and QMS platforms.
• Full Bilingual English and Spanish

Physical Requirements

• Ability to stand for extended periods.
• Ability to lift, push, or pull materials (within company guidelines).
• 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

This job description describes the essential functions of the position at the time the job description was created, but is not an exhaustive list of tasks, duties and responsibilities. In addition, the position may evolve or change over time, and such changes will not be reflected in the job description until it is updated again.

We All Belong

ITG Brands are equal employment opportunities providers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, hair texture, sexual orientation, gender identity, national origin, disability, or protected veteran status.

All applicants must consent to an independent investigation of their background, references, previous employment, education, criminal history, and drug testing.