Associate Manager, Quality Systems

About the role

The Associate Manager, Quality Systems leads a team responsible for maintaining and continuously improving quality processes, ensuring regulatory compliance and patient safety across the organization.

Key responsibilities

• Lead and develop a team of Quality Systems professionals, setting objectives and supporting career growth.
• Manage quality system processes such as CAPA, document control, change management and quality records to meet ISO 13485 and FDA requirements.
• Coordinate internal and external audits, drive audit readiness and ensure timely closure of observations.
• Partner with cross‑functional teams to investigate issues, implement corrective actions and reduce compliance risks.
• Deliver and maintain training programs for quality systems, keeping records current and compliant.

Required profile

• Bachelor’s degree or equivalent with at least 6 years of experience in Quality Assurance, Quality Systems or Regulatory Affairs.
• Proven experience in medical device quality and regulatory environments, including ISO 13485 and FDA regulations.
• Demonstrated ability to lead and develop teams in an international, cross‑functional setting.
• Fluent English (minimum B2) and advanced proficiency with standard business applications.

Required skills

• ISO 13485 compliance
• FDA quality system regulations
• CAPA (Corrective and Preventive Actions) management
• Document control and change management
• Audit coordination and readiness
• Medical Device Single Audit Program (MDSAP) knowledge