Quality Engineer--Manufacturng

• 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, come-up 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. 7. 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

• Production output and throughput targets.
• Accuracy and quality rates.
• Adherence to safety, regulatory, and compliance standards.
• Equipment uptime, utilization, and operational efficiency.
• On-time completion and schedule adherence.
• Participation in and contribution to continuous improvement initiatives.

• 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.

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