Quality Assurance Supervisor

JobSquad Staffing Solutions; Town of Florida (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

JobSquad Staffing Solutions seeks a Quality Assurance Supervisor to lead the QA team on the second shift, ensuring regulatory compliance and maintaining quality systems across manufacturing operations.

The ideal candidate will have deep knowledge of cGMP, FDA regulations, ISO 9001, CAPA, audits, validation, calibration, and continuous improvement methods such as Lean Six Sigma. Leadership experience is required to mentor QA staff and coordinate with Production, Engineering, and Suppliers.

Qualifications

• Experience in a manufacturing QA environment with leadership responsibilities.
• Demonstrated knowledge of FDA regulations, cGMP, ISO 9001, and CAPA processes.
• Proven ability to perform root cause analysis, audits, validation, and calibration.
• Experience applying Lean Six Sigma and 5S/Kaizen for continuous improvement.

Responsibilities

• Lead the Quality Assurance team and manage daily QA activities.
• Maintain and improve quality systems to ensure regulatory compliance.
• Drive CAPA and root cause analysis across products and processes.
• Support QMS implementation and audits, internal and supplier.
• Lead continuous improvement initiatives using Lean Six Sigma methodologies.
• Oversee calibration programs and validation protocols.
• Coach Quality Inspectors and collaborate with Production, Engineering, and Suppliers.

Skills

Quality Assurance

cGMP

FDA regulations

ISO 9001

CAPA

Root cause analysis

Audits

Validation

Calibration

Quality systems

Lean Six Sigma

5S

Kaizen

Tools

QMS software

Job description

We are seeking a highly motivated and detail-oriented Quality Assurance Supervisor to join our manufacturing team. This position will lead the Quality Assurance team, maintain and improve quality systems, ensure regulatory compliance, and support continuous improvement initiatives throughout the organization.

This is a second shift opportunity M-F 2pm - 10pm.

The ideal candidate will have strong experience with cGMP, FDA regulations, ISO 9001, CAPA, root cause analysis, audits, validation, calibration, and quality systems, along with previous leadership experience in a manufacturing environment.

Key Responsibilities

• Ensure adherence to the company Quality System and applicable regulatory requirements.
• Lead root cause analysis and corrective/preventive actions (CAPA).
• Support implementation and maintenance of the Quality Management System (QMS).
• Drive continuous improvement initiatives utilizing 5S, Kaizen, Lean, and Six Sigma methodologies.
• Develop and conduct quality awareness and compliance training.
• Support Engineering and Operations with the transfer of products and processes into Production.
• Provide leadership and support to Quality Inspectors and ensure compliance with QMS requirements.
• Conduct and support internal and external audits and ensure findings are properly addressed.
• Investigate product failures and customer complaints and implement corrective actions.
• Develop, maintain, and revise quality manuals, procedures, SOPs, and controlled documentation.
• Oversee receiving and outgoing quality activities.
• Improve receiving inspection processes and procedures.
• Investigate supplier quality failures and implement corrective actions.
• Monitor and evaluate supplier quality performance.
• Develop and maintain quality reports and metrics.
• Establish and maintain appropriate measurement methods and equipment.
• Analyze quality data and utilize problem-solving techniques to improve manufacturing processes.
• Train Quality and Production personnel on quality procedures and requirements.
• Work cross-functionally with Production, Engineering, Purchasing, suppliers, and customers to resolve quality issues.
• Support Lean and Six Sigma continuous improvement initiatives.
• Ensure compliance with applicable ISO 9001, OSHA, FDA, and GMP requirements.
• Maintain and oversee the calibration program.
• Develop and execute validation protocols and the Validation Master Plan.
• Provide leadership, coaching, training, and development to Quality personnel.

Qualifications

• Previous Quality Assurance/Quality Control experience within a manufacturing environment.
• Previous experience leading or supervising Quality personnel.
• Strong knowledge of FDA regulations, cGMP, ISO 9001, QMS, CAPA, root cause analysis, audits, validation, and calibration.
• Experience with Lean/Six Sigma and continuous improvement methodologies preferred.
• Strong documentation, analytical, problem-solving, communication, and leadership skills.