Director of Quality Assurance (QA)

Position:                        Director of Quality Assurance (QA)                          

Department:                Quality Assurance

Reports to                     Operations Director       

Direct Reports:            QA Manager, R&D Tech, QA Staff

Classification:             Full Time - Exempt

General Description

The Director of Quality Assurance (QA) is charged with the oversight of quality control, food safety, product development, and regulatory adherence for a USDA facility specializing in cooked meat and vegetable products. This position leads the initiative to ensure products consistently meet or surpass USDA/FDA standards, customer expectations, and the company's internal quality standards. The Director spearheads the QA department, formulates quality programs, and cultivates an atmosphere of collaboration.

Essential Duties

• Supplier & Product Quality Management:
  • Lead the development and execution of quality programs, including Supplier Qualification, QA Agreements, Non-conformance Management, CAPA, and Product Specification Management.
  • Ensure that all product specifications and standards set forth by R&D and customers are followed and that any deviations from set specifications are corrected and reported appropriately
  • Assess and approve suppliers based on quality criteria; work with procurement to ensure materials meet required standards.
  • Maintain ingredient and packaging material documentation including current specifications, SDS, Nutritional Data, Letters of Guarantee, etc., as required
• Regulatory & Compliance Oversight:
  • Manage regulatory activities related to Change Control, Artwork and Promotional Material Review, Product Claim Approval, and label approval to ensure adherence to USDA / FDA, and other relevant guidelines.
  • Manage non-compliance issues, initiating corrective actions when deviations from quality standards are detected.
  • Monitor the equipment calibration status and certification of all measuring and testing devices in the facility and see that they are renewed as required
• Performance Monitoring & Continuous Improvement:
  • Define and track Key Performance Indicators (KPIs) for co-manufacturers to foster continuous quality improvement. Lead supplier audits and regular site visits to assess GMP compliance and resolve quality concerns.
• Cross-Functional Leadership:
  • Collaborate with internal teams (e.g., manufacturing, R&D, marketing) to ensure seamless integration of quality standards into new product development, commercialization, and ongoing product lifecycle management.
  • Drive continuous improvement initiatives to enhance quality, reduce waste, and increase efficiency across departments.
  • Develop and deliver training programs on quality assurance, food safety, and compliance to all plant employees.
• Risk Management & Gap Analysis:
  • Conduct regular risk assessments, including gap analyses of Food Safety and Quality Programs, sanitation validation, and audit preparedness. Implement corrective actions and process improvements as needed.
• CAPA & Corrective Action Leadership:
  • Lead the CAPA process, ensuring timely detection, investigation, root cause analysis, and corrective action implementation. Verify the effectiveness of corrective actions to mitigate quality risks.
  • Conduct root cause analysis for quality issues and implement preventive measures.

• Regulatory Strategy & Substantiation:
  • Provide strategic regulatory guidance, including developing structure-function claims, ensuring product labeling compliance, and supporting product certifications (e.g., organic, non-GMO, Halal etc.).
• Audit & Certification Management:
  • Lead facility and product certification audits, ensuring compliance with relevant standards. Streamline and maintain certification processes, including ensuring regulatory readiness and plant audit preparedness.
  • Prepare for and lead internal and external audits, including third-party audits for certifications like SQF or BRC. Implement corrective actions based on audit results to maintain or achieve certifications.
  • Maintain accurate, detailed records of quality inspections, audit findings, and corrective actions.
  • Ensure all documentation is compliant with regulatory requirements and internal policies.
• Stakeholder Engagement:
  • Build and maintain relationships with external regulatory authorities and partners, facilitating communication on compliance, adverse event reporting, and quality management.
  • Serve as the primary contact for quality-related customer inquiries or complaints; ensure timely and effective response and resolution.
• Administration:
  • Foster a positive work environment that promotes team development and encourages adherence to quality standards.
  • Supervise and support direct reports, including regular job performance evaluations, payroll and employee relations.
  • Maintain confidentiality of information and documents such as product specifications, financial documents, personnel records, marketing forecasts, customer information, vendor information, and salary information

Key Achievements:

• Spearheaded the improvement of Food Safety and Quality programs, ensuring compliance with evolving regulations and industry standards.
• Led successful audits and inspections, achieving consistently high standards of GMP and regulatory compliance.
• Reduced time-to-market for new products by optimizing regulatory submission processes and streamlining claim substantiation and label approval workflows.

Minimum Qualification and Requirements

Education:

Bachelor’s degree in food science, Microbiology, Chemistry, or a related field.

Experience:

Minimum of 5-7 years of experience in QA management within a USDA or FDA inspected food processing plant.

Proven track record in implementing quality systems, managing audits, and ensuring regulatory compliance.

Skills:

• Strong leadership and team management capabilities.FDA-inspected
• Excellent problem-solving skills with a focus on quality and process improvement.
• Proficient in food safety protocols, including HACCP, GMP, SSOP, and SQF or BRC standards.
• Good communication skills for interfacing with regulatory bodies, customers, and staff.
• Detail-oriented with exceptional organizational skills.

Certifications: HACCP & PCQI certification is required

Physical Requirements and Work Environment

Physical Demands:

Professional Office setting and to the Plant. Requires prolonged walking, sitting, bending, stooping and telephone/radio communications. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to walk and use hands. The employee is occasionally required to stand; sit; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment: The work environment characteristics described here represent those an employee encounters while performing the essential functions of this job. While performing these duties, the employee is regularly exposed to refrigerated and wet conditions. The noise level in the work environment is usually moderate to loud.

Schedule

In Person, Monday to Friday, and some weekends as needed.

Hours may vary depending on the business needs.

The position is based in our San Leandro Office. Occasional travel as needed for inspection of equipment and/or training on both Oakland and San Leandro Plant.