Quality Assurance Leader — ISO/GMP Excellence

Harmony Systems & Service, LLC; Dayton (OH); On-site; USD 85,000 - 125,000; Full time

Job summary

Harmony Systems & Service, LLC is seeking a dynamic Quality Manager to lead our quality assurance and control initiatives across manufacturing operations. This pivotal role drives development, implementation, and continuous improvement of quality systems to ensure products meet safety, regulatory, and performance standards.

You will lead cross-functional teams, conduct regular QA/QC audits, oversee inspections and testing, and champion a culture of lean, Six Sigma methodologies to elevate

Qualifications

• Develop and maintain ISO 9001-aligned quality management systems.
• Lead regular quality audits across production.
• Oversee inspection, testing, and validation of materials and products.
• Ensure regulatory compliance with ISO, GAMP, GD&T.
• Manage and develop a quality team.
• Collaborate with manufacturing, engineering, supply chain, and regulatory affairs.
• Analyze audit data to identify root causes and implement corrective actions.

Responsibilities

• Develop, implement, and maintain comprehensive quality management systems aligned with ISO 9001 standards and other regulatory frameworks.
• Lead regular quality audits across production processes to identify areas for improvement, ensuring adherence to HACCP, CGMP, Lean management, and Six Sigma methodologies.
• Oversee quality inspection procedures, ensuring rigorous testing and validation of raw materials, in-process components, and finished products against established quality standards.
• Ensure compliance with all regulatory and legal requirements by staying current with industry standards such as ISO, GAMP, GD&T (Geometric Dimensioning & Tolerancing), and other applicable regulations.
• Manage a team of quality professionals by providing training, guidance, and performance feedback to foster a high-performance culture focused on continuous improvement.
• Collaborate with cross-functional teams including manufacturing, engineering, supply chain, and regulatory affairs to integrate quality assurance into all stages of production.
• Analyze data from quality audits, inspection reports, and process controls to identify trends, root causes of defects or non-conformities, and implement corrective actions promptly.

Skills

Quality management

ISO 9001

GMP/GxP compliance

Six Sigma DMAIC

Quality audits

Data analysis

Leadership

Cross-functional collaboration

Regulatory compliance

QA/QC software

Job description

Harmony Systems & Service, LLC is seeking a dynamic Quality Manager to lead our quality assurance and control initiatives across manufacturing operations. This pivotal role drives development, implementation, and continuous improvement of quality systems to ensure products meet safety, regulatory, and performance standards.

You will lead cross-functional teams, conduct regular QA/QC audits, oversee inspections and testing, and champion a culture of lean, Six Sigma methodologies to elevate