Associate Manager, Quality Systems

Quality systems play a critical role in ensuring product quality, regulatory compliance, and patient safety. As Associate Manager, Quality Systems, you will lead a team responsible for maintaining and continuously improving quality processes while partnering across the organization to drive compliance, operational excellence, and sustainable business growth.

What You Will Do

• Lead and develop a team of Quality Systems professionals by setting clear objectives, providing coaching, and supporting career development to achieve quality and compliance goals.
• Manage quality system processes, including corrective and preventive actions, document control, change management, and quality records, ensuring compliance with applicable regulations and internal standards.
• Ensure ongoing compliance with global quality and regulatory requirements, including ISO 13485 and applicable FDA regulations.
• Coordinate and support internal and external audits, drive audit readiness activities, and ensure timely closure of audit observations and corrective actions.
• Partner with cross-functional teams to investigate quality issues, implement corrective and preventive actions, and reduce compliance risks.
• Oversee the documentation, review, investigation, and resolution of nonconformances in accordance with established procedures.
• Deliver and maintain quality systems training programs, ensuring training records and certifications remain current and compliant.
• Drive continuous improvement initiatives by monitoring quality system performance, analyzing trends, and implementing process enhancements that improve effectiveness and reduce risk.

What You Will Need

Required Qualifications

• Bachelor’s degree or equivalent
• Minimum 6 years of experience in a Quality Assurance, Quality Systems, or Regulatory Affairs function.
• Experience working with medical device quality and regulatory requirements, including ISO 13485 and FDA quality system regulations.
• Experience supporting or managing quality system processes such as audits, management reviews, quality planning, document control, corrective and preventive actions, and change management.
• Experience interacting with regulatory authorities and external auditors.
• Experience leading and developing teams and working in a cross-functional, international environment.
• Fluent English (minimum B2 level), written and spoken.
• Advanced proficiency with standard business and computer applications.

Preferred Qualifications

• Master’s degree or PhD.
• Professional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification.
• Knowledge of Medical Device Single Audit Program (MDSAP) requirements and other international medical device regulations.