Quality Manager

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

We are seeking a dynamic and detail-oriented Quality Manager to lead our quality assurance and control initiatives across manufacturing operations. In this pivotal role, you will champion the development, implementation, and continuous improvement of quality systems to ensure products meet the highest standards of safety, compliance, and excellence. Your leadership will drive a culture of quality, foster cross-functional collaboration, and uphold regulatory and legal standards to support our commitment to delivering superior products to our customers. This is an exciting opportunity for a proactive professional passionate about elevating quality management practices in an industrial or manufacturing setting.

Responsibilities

• Develop, implement, and maintain comprehensive quality management systems aligned with ISO 9001 standards and other relevant regulatory frameworks such as FDA regulations and GMP guidelines.
• 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

• Proven experience practicing in an industrial or manufacturing engineering role with a strong understanding of manufacturing processes and quality control principles.
• Expertise in ISO 9001 standards along with knowledge of ISO requirements; familiarity with ISO 13485 or other industry-specific standards is a plus.
• Strong knowledge of HACCP principles, CGMP regulations, FDA compliance standards, GMP practices, and regulatory/legal compliance in production environments.
• Skilled in conducting thorough quality audits utilizing tools such as Six Sigma DMAIC methodology; proficiency in GxP (Good Practice) guidelines is desirable.
• Excellent analysis skills with the ability to interpret complex data sets for process improvements; experience with QA/QC software systems preferred.
• Effective team leadership capabilities combined with cross-functional communication skills to drive organizational alignment on quality initiatives.
• Project management expertise to oversee multiple initiatives simultaneously while maintaining focus on strategic goals related to lean management and continuous improvement.

Join us as we strive for excellence in every product we deliver! Your expertise will help shape our future by ensuring the highest levels of quality assurance while fostering innovation within our manufacturing environment.