Quality & Process Improvement Lead

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$95,000.00/yr - $/yr

The Quality & Process Improvement Lead is responsible for maintaining and improving the organization’s quality management system (QMS). This involves leading the Quality Assurance (QA) staff, handling investigations, deviations, and change controls while collaborating with cross‑functional teams, and ensuring all procedures, training, and records meet regulatory and internal compliance standards. This leader will work extensively across all business functions to proactively identify and resolve quality challenges.

• Conduct thorough root cause analyses for deviations, exceptions, complaints, and Out‑of‑Specification (OOS) results, and prepare formal investigation reports to drive remediation.
• Collaborate with Senior Regulatory Compliance/QA Manager to assess and manage the impact of quality issues on product integrity and regulatory standing.
• Collaborate with Director of Quality and Senior Regulatory Compliance/QA Manager on resolving quality issues.
• Review and approve quality records, training documentation, and Standard Operating Procedures (SOPs) as provided by QA managers, ensuring accuracy, completeness, and compliance.
• Oversee the internal audit and stability program.
• Collaborate extensively with cross‑functional teams across the organization (e.g., Operations, R&D, and Procurement) to proactively identify, address, and resolve quality issues.

• The candidate must be legally authorized to work in the United States.
• Bachelor’s degree in a relevant field (e.g., science, engineering, quality management).
• 5+ years of experience in QA/QC.
• Leadership experience and ability to manage teams.
• Language proficiency – English required;
  Spanish preferred.
• Computer skills – proficient with Microsoft Office applications.
• Communication skills – strong verbal, written, and presentation skills.
• Task management – works in coordination with assigned project plans and goals.
• Attention to detail – ensures quality parameters are consistently followed and deviations from SOPs are addressed or reported.

Able to work in an environment exposed to powders, chemicals, and food allergens.