Quality Assurance Manager

Position Overview

We are seeking a hands-on Quality Assurance Manager to lead and maintain the Quality Management System (QMS) and drive continuous improvement across manufacturing operations. This position provides leadership for quality systems, compliance, inspection processes, corrective action, and quality initiatives while partnering closely with Operations and other internal and external stakeholders to support quality, efficiency, and operational excellence.

Key Responsibilities

• Manage and maintain the ISO 9001:2015 Quality Management System, including serving as Management Representative and overseeing third-party and external audits.
• Oversee manufacturing process flow and ensure adherence to established quality standards.
• Promote and develop a quality-first culture throughout the organization.
• Lead and manage Quality department personnel and inspection activities, including incoming, in-process, final, and first-article inspections as needed.
• Manage corrective action and CAPA processes to ensure root-cause resolution and prevention of recurrence.
• Develop and implement proactive quality assurance plans, process controls, and preventive measures.
• Validate quality processes through audits, data analysis, and investigation of customer complaints.
• Collaborate with Operations to develop and implement effective manufacturing methods, process improvements, and training programs.
• Oversee gage calibration processes and related compliance requirements.
• Manage PPAP, ISIR, certification, and other applicable quality compliance requirements.
• Develop high-performance quality systems and processes that support manufacturing objectives.
• Perform additional duties and responsibilities as assigned by the General Manager.

Qualifications & Core Competencies

• Minimum of 5 years of experience managing a manufacturing Quality Assurance department.
• 5 years of experience in Quality Management and manufacturing operations.
• Strong knowledge of ISO 9001:2015; ISO 13485 experience is also valued.
• Demonstrated experience leading audits and managing a Quality Management System.
• Strong knowledge of quality methodologies such as Lean, Six Sigma, and Theory of Constraints.
• Proven leadership ability with a hands-on management style and strong presence on the manufacturing floor.
• Excellent organizational and project management skills.
• Strong analytical, critical-thinking, problem-solving, and root-cause analysis skills.
• Ability to communicate effectively with internal and external stakeholders.
• Demonstrated ability to lead quality initiatives and develop effective quality systems and processes.
• Ability to develop and implement additional certifications and compliance requirements as needed.