Quality Engineer

Key Responsibilities

• Ensure compliance with FDA LACF regulations (21 CFR Part 113) and related food safety requirements.
• Maintain and support Scheduled Process filings (FDA Form 2541) in coordination with Process Authorities.
• Verify adherence to thermal process parameters (time, temperature, pressure, venting, comeup time).
• Support and maintain compliance with HACCP, Preventive Controls (FSMA), and GMPs.
• Act as a subject matter expert for retort processing compliance and deviation handling.
• Monitor and validate retort operations, this will include Temperature distribution (TD), heat penetration (HP) studies, Venting and air removal verification, and Critical factor control operations.
• Investigate and document process deviations, including thermal process deviations, and lead corrective actions.
• Collaborate with Process Authorities to establish and optimize scheduled processes.
• Ensure calibration and proper functioning of critical instruments (temperature probes, pressure gauges, recorders).
• Develop, implement, and maintain SOPs, work instructions, and quality documentation.
• Perform internal audits and support third-party or regulatory inspections.
• Maintain records per LACF requirements (retort logs, deviation logs, calibration records).
• Lead or participate in root cause analysis (RCA) and CAPA processes.
• Lead validation activities for new products, processes, or equipment related to retort systems.
• Analyze process data and recommend improvements to enhance product quality, safety, and efficiency.
• Support continuous improvement initiatives (Lean, Six Sigma, OEE improvements).
• Implement statistical analysis methods to improve process capability and consistency.
• Train operations and quality personnel on LACF requirements, retort procedures, critical limits, and Food safety and quality standards.
• Provide technical support to production, R&D, and maintenance teams.
• Participate in product development to ensure processes meet regulatory and safety requirements.

Qualifications

• Bachelor’s degree in Food Science, Chemical Engineering, Microbiology, or related field required.
• Three to Five (3-5) years of experience in food or beverage manufacturing required, with knowledge preferably in LACF / acidified foods and Retort Processing.
• Experience working with FDA regulations and audits is strongly preferred.
• Certifications in BPCS, PCQI, and Six Sigma strongly preferred.
• Fluency in English is a must, Spanish a plus.