Quality Manager(Medical Device)

Quality Manager – Medical Device

Job Summary

We are seeking an experienced Quality Manager with a strong background in the medical device industry. The ideal candidate will have experience in quality assurance, FDA regulations, ISO standards, quality management systems, audits, CAPA, and continuous improvement.

Key Responsibilities

• Manage daily quality assurance activities and ensure compliance with regulatory requirements.
• Develop, implement, and maintain quality management systems (QMS).
• Ensure compliance with FDA regulations and ISO standards.
• Lead internal, external, supplier, and regulatory audits.
• Manage CAPA, investigations, corrective actions, and quality improvements.
• Oversee supplier quality and vendor compliance.
• Maintain quality documentation, procedures, and training programs.
• Monitor quality performance and identify opportunities for improvement.
• Work closely with engineering, manufacturing, and regulatory teams to resolve quality issues.
• Support regulatory inspections and maintain audit readiness.
• Lead and develop quality team members.

Qualifications

• Bachelor's degree in Science or a related field.
• 7–10 years of quality assurance experience, preferably in the medical device industry.
• Strong knowledge of FDA 21 CFR Parts 820, 11, and 58.
• Experience with ISO 13485, ISO 9001, ISO 14971, and ISO 14155.
• Strong background in QMS, CAPA, audits, regulatory compliance, and continuous improvement.
• Experience managing quality teams and working with cross-functional departments.
• Strong communication, leadership, and problem-solving skills.
• Experience with FDA inspections and notified body audits.
• Knowledge of MasterControl or similar quality management systems.
• Experience with supplier quality and regulatory compliance.