Quality Operations Lead

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We are seeking a Quality Operations Lead to support the Production Quality Assurance team and maintain critical quality systems at our Carlsbad facility.

In this role, you will provide day-to-day leadership to Quality Assurance Technicians, support production coverage, lead audits and investigations, and drive improvements across the facility’s quality systems. This is an excellent opportunity for a quality professional who enjoys solving problems, improving processes, working cross-functionally, and helping ensure products consistently meet customer and regulatory requirements.

• Maintain and continuously improve quality systems, including internal audits, change control, document control, CAPA, and other applicable programs.
• Provide day-to-day leadership and guidance to Quality Assurance Technicians and help address production coverage needs.
• Ensure the timely reporting and analysis of quality metrics, including process capability, control charts, and measurement quality.
• Lead internal and external quality audits and support the development of audit responses, corrective-action plans, and completion timelines.
• Perform root-cause analyses and other problem-solving activities to identify effective corrective actions and process improvements.
• Review and trend statistical data to evaluate the effectiveness of established quality systems and support sound product-quality decisions.
• Review customer product specifications to determine applicable quality requirements and responsibilities.
• Partner with customers, suppliers, Manufacturing, and Product Development to resolve quality issues and identify improvement opportunities.
• Manage customer quality complaints from initial information gathering and investigation through root-cause analysis, corrective action, and formal customer response.
• Maintain the CAPA program, ensuring corrective-action requests are completed on time and implemented actions effectively address identified issues.
• Review and approve deviations related to production issues.
• Report quality issues, trends, risks, and losses to management.
• Create and revise technical documents, including standard operating procedures, product specifications, safety data sheets, allergen statements, GMO statements, and irradiation or ETO statements.
• Represent the Quality department in cross-functional meetings to resolve quality, technical, and service-related issues.
• Perform other duties and provide additional departmental support as assigned.

• Bachelor’s degree in Manufacturing Engineering, Food Science, Biological Sciences, or a related discipline; significant relevant quality assurance experience may be considered in place of a technical degree.
• At least two years of experience implementing or maintaining quality systems, including at least one year in a quality position within a food manufacturing environment.
• Experience with in the dietary supplement, nutritional product, food, or pharmaceutical industry is preferred.
• Previous supervisory, team‑lead, or informal leadership experience is preferred.
• Experience applying FDA current Good Manufacturing Practices in a manufacturing environment.
• Experience designing, implementing, or improving quality systems.
• Strong working knowledge of HACCP, statistical process control, inspection methods, quality‑control techniques, and related documentation.
• Experience supporting audits, investigations, root‑cause analyses, CAPA, deviations, and customer complaint resolution.

The opportunity will be based onsite at our Carlsbad facility.

Periodic domestic travel and…