Quality Engineer/Specialist
About the job
- A Bachelor's degree in Engineering or a related field and at least four years of previous exposure to audit observations, investigations, and corrective and preventive action activities within a regulated industry.
- Bilingual proficiency in Spanish and English.
- Experience with the nonconformance/corrective and preventive action and audit observations processes.
- Experience with FDA 21 CFR and global medical device regulations and standards.
- Experience with Good Manufacturing Practice and Good Documentation Practice regulations.
- Initiate nonconformance reports as required.
- Perform investigations in ETQ for nonconformance reports, corrective and preventive actions, and audit observations for Operations.
- Plan and execute product disposition.
- Plan and execute actions related to nonconformance/corrective and preventive action activities and audit observations.
- Close investigations and product dispositions on time.
- Identify and escalate compliance issues and their potential impact across the franchise to Operations Managers for resolution.
- Review and analyze quality trends with the manufacturing team.
- Use quality trends to provide direction in setting work priorities for process enhancement.
- Provide leadership and guidance to cross-functional, multilevel technical teams to identify and understand causes of nonconformance and implement sound corrective and preventive actions.
- Evaluate implemented corrective and preventive actions against trends to assess their effectiveness.
- Lead investigations of negative trends and, in alignment with the Process Engineer and Manufacturing Manager, facilitate implementation.
- Analyze data and recommend actions for process, equipment, and system improvement based on trends.
About the company
FITS, LLC provides integrated engineering, compliance, and technical services to pharmaceutical, biotech, medical device, and healthcare organizations in Puerto Rico. It covers commissioning, qualification and validation (CQV), utilities and facilities engineering, maintenance, EHS, automation, and technical staffing to help clients maintain FDA-compliant operations and improve performance of mission-critical systems. Acting as an extension of client operations, FITS delivers turnkey projects, regulatory readiness, quality assurance, and continuous improvement with a multidisciplinary team to support site expansions and ongoing operations. Its goal is to help life-sciences and healthcare facilities scale safely and efficiently while ensuring reliable, compliant operations.
Company Size
51-200
Company Stage
Growth Equity (Non-Venture Capital)
Total Funding
$8M
Headquarters
Aguada, Puerto Rico
Founded
2008
Get referred to Flexible & Integrated Technical Services
See people who can refer or advise you
Simplify's Take
What believers are saying
- FITS posted active 2026 openings in validation, C&Q, project management, and process development.
- Its 2026 jobs span Juncos, Dorado, Yauco, and Juana Díaz, signaling broad demand.
- Federal contractor registration with SAM.gov expands access to government-funded facilities work.
What critics are saying
- FITS depends on contract hiring, exposing revenue to client shutdowns and procurement delays.
- Heavy concentration in Puerto Rico life sciences ties FITS to local plant expansions and slowdowns.
- A rival integrator winning Amgen or J&J accounts would immediately compress FITS utilization.
What makes Flexible & Integrated Technical Services unique
- FITS embeds CQV, utilities, and technical staffing inside Puerto Rico regulated plants.
- Clients include Amgen, Lilly, Bristol Myers Squibb, Abbott, Johnson & Johnson, and CooperVision.
- Founded 2008, FITS combines engineering, maintenance, and validation under one local service platform.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Flexible Work Hours