Quality Lead

Job Summary

We are seeking an experienced Quality Lead for a direct hire opportunity in Cayey, PR. This high-impact role provides strategic leadership for the Quality function within a regulated manufacturing operations environment, ensuring compliance with FDA, ISO, GMP, and corporate quality standards.

The Quality Lead will serve as a key partner to Operations, Engineering, Product Development, and leadership teams to strengthen quality systems, improve manufacturing performance, and drive a proactive culture of compliance and continuous improvement. This is an excellent opportunity for a bilingual quality professional who enjoys visible leadership, cross-functional collaboration, and the opportunity to influence quality strategy in a global manufacturing setting.

This role offers strong professional growth, supportive leadership, meaningful operational impact, and a unique international training opportunity in Europe during the first three months.

Key Responsibilities

- Lead quality strategy and execution in alignment with FDA, ISO, GMP, QMS, and corporate requirements.
- Serve as the primary Quality representative for audits, FDA inspections, regulatory interactions, and compliance activities.
- Manage CAPA processes, root cause analysis, corrective actions, and quality system improvements.
- Monitor quality KPIs, analyze trends, and drive data-based continuous improvement and defect reduction initiatives.
- Partner with Operations, Engineering, and Product Development to optimize processes, specifications, documentation, and quality outcomes.
- Promote a strong quality culture through training, self-inspection practices, SOP compliance, and continuous improvement programs.

Compensation and Benefits

- Direct hire opportunity.
- 401(k) match up to 3%.
- Weekly payroll.
- 15 vacation days plus paid holidays.
- Medical, dental, vision, and life insurance.
- Employee stock savings plan.
- Educational assistance.
- Wellness programs and health fair.
- Employee recognition programs.
- Occupational clinic.
- 3-month training program in Europe.

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Additional Skills

Required Qualifications and Skills

- Lead Quality strategy and compliance programs across regulated manufacturing operations.
- Manage audits, inspections, CAPA, quality KPIs, documentation, and QMS activities.
- Drive root cause analysis, corrective actions, process improvement, PQRS, and defect reduction initiatives.
- Collaborate cross-functionally with Operations, Engineering, and Product Development to improve quality performance.

- Bachelor’s Degree in Science or Engineering required.
- 5 to 7+ years of experience in FDA-regulated manufacturing required.
- Leadership experience in Quality roles required.
- Strong knowledge of FDA regulations, GMP, ISO 9001, CAPA, and QMS systems required.
- Six Sigma Green Belt required.
- Experience with quality tools such as SAP, TrackWise, Minitab, JMP, or similar platforms required.
- Full bilingual fluency in English and Spanish required.
- Must be available to complete a 3-month training program in Europe.
- Strong analytical, problem-solving, communication, and cross-functional leadership skills required.

Preferred Qualifications

- Master’s Degree in Science, Engineering, Quality, or a related field preferred.
- Six Sigma Black Belt preferred.
- Experience leading FDA inspections or serving as a primary Quality representative during regulatory audits preferred.
- Experience driving quality transformation, defect reduction, and continuous improvement initiatives in a global manufacturing environment preferred.