Quality Manager

The Quality Manager is responsible for leading the organization's Quality Management System (QMS), ensuring compliance with international standards, enhancing product quality, and supporting continuous improvement across production and operations. This role works closely with cross‑functional teams, oversees quality personnel, and serves as the Management Representative for standards such as ISO 9001, AS9100, and ISO 13485.

Key Responsibilities

• Lead and maintain the Quality Management System, ensuring compliance with ISO, AS, and GMP requirements.
• Promote a strong quality culture and ensure organization-wide understanding of quality standards.
• Oversee internal audits, external audits, corrective actions, preventive actions, and non‑conformance management.
• Develop and implement quality strategies, procedures, and documentation.
• Support product and process validation, equipment qualification, and quality engineering activities.
• Analyze production and quality data to drive improvements in efficiency, safety, and product performance.
• Manage document control, calibration systems, and quality records.
• Respond to customer issues and lead investigations, including recalls or advisory notices when applicable.
• Provide regular quality performance reporting to senior leadership.
• Serve as process owner for key ISO 13485 elements (e.g., complaints, internal audits, management review, CAPA, feedback).

Qualifications

• Bachelor's degree or equivalent experience.
• 5+ years in quality assurance or quality control within manufacturing or production environments.
• Supervisory or leadership experience required.
• Strong understanding of quality principles, regulations, and measurement systems.
• Familiarity with ISO 9001, ISO 13485, AS9100, and ISO 14001 requirements.
• Excellent communication, problem‑solving, organizational, and analytical skills.
• Ability to work collaboratively, manage deadlines, and address issues professionally at all levels.