Job Description

About the Role

The Director of Quality Assurance is a senior leadership role responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) aligned with ISO 9001:2015 standards. This position ensures product quality, regulatory compliance, and continuous process improvement across manufacturing operations. The role is essential in driving operational excellence, reducing risk, and enhancing customer satisfaction through effective quality assurance strategies.

Responsibilities:

• Lead company-wide quality assurance initiatives to drive continuous improvement and compliance.
• Develop, implement, and oversee a quality management system (QMS) that meets ISO 9001:2015 and other regulatory standards.
• Ensure organizational compliance with national and international quality regulations and manufacturing standards.
• Supervise quality audits, inspections, and testing procedures to ensure product quality and consistency.
• Create and maintain technical and quality documentation, including PPAPs, Corrective Actions (CAR), Preventive Actions (PAR), and Non-Conformance Reports (NCP).
• Manage quality control for incoming materials, in-process production, and finished goods.
• Define and execute quality assurance goals, KPIs, policies, and standard operating procedures (SOPs).
• Collaborate with manufacturing, supply chain, and engineering teams to align quality objectives with business goals.
• Monitor and analyze quality metrics, producing data-driven performance reports.
• Serve as the primary liaison with third-party auditors and regulatory agencies.
• Deliver internal training on quality standards, procedures, and compliance best practices.
• Identify and implement best practices in lean manufacturing, Six Sigma, and risk management.
• Stay current with industry trends and changes in regulatory requirements.

Qualifications:

• Bachelors degree in Quality Management, Engineering, or related field; or a minimum of 4 years' experience in a senior quality assurance role.
• Deep expertise in ISO 9001:2015 standards and QMS implementation.
• Strong background in manufacturing quality assurance, supplier quality management, and compliance auditing.
• Excellent communication, leadership, and project management skills.
• Experience with third-party audits, CAPA processes, and regulatory compliance.
• Ability to travel as required for audits, inspections, and supplier evaluations.

Desired Qualifications:

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification.
• Experience in regulated industries such as automotive, aerospace, or medical device manufacturing.
• Proficiency with quality management software (QMS tools), SPC, and data analysis platforms.
• Proven track record of driving ISO certification and continuous improvement initiatives.
• Familiarity with lean manufacturing principles and root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagrams).

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