SUMMARY:
Quality Application Specialist to support product transfer, process validation, and commercialization activities within a regulated medical device manufacturing environment. The selected candidate will provide quality oversight for sterilization and final packaging processes, support product release activities, perform statistical analysis, and drive First Time Quality initiatives.

REQUIREMENTS:

• Bachelor's Degree in Engineering or Science.
• 3–6 years of experience in Medical Device, Pharmaceutical, Biotechnology, or other FDA-regulated industries.
• Experience with Process Validation (IQ/OQ/PQ), Statistical Analysis, and PFMEA.
• Knowledge of Sterilization processes and Final Packaging operations.
• Experience working in GMP-regulated environments.
• Strong analytical, problem-solving, and technical writing skills.

PREFERRED QUALIFICATIONS:

• Experience with DOE, CAPA, Change Control, and Computer System Validation (CSV).
• Product transfer and commercialization experience.
• Knowledge of FDA regulations and quality systems.

WORK METHODOLOGY:

• 100% on-site job
• Full time job
• Location: Juncos, PR
• Administrative shift (willing to work weekend when needed) 
• Type of industry: Medical devices
• Timeframe: May 2028