Audira Medtech is a hearing healthcare technology company focused on developing innovative hearing aid and audiology solutions that improve patient outcomes and quality of life.

• About the Role

We are seeking an experienced Quality Assurance Director to lead quality systems and compliance for our hearing aid medical device operations in Singapore. You will be responsible for ensuring product safety, regulatory adherence, and continuous improvement across all QA processes.

• Key Responsibilities

• Oversee and maintain QMS in compliance with ISO 13485, FDA, EU MDR, and HSA regulations.
• Lead internal audits, regulatory inspections, and quality risk management.
• Drive product quality assurance from design through manufacturing and post-market.
• Develop QA policies, procedures, and training programs across the organization.
• Partner with R&D, Manufacturing, and Regulatory teams to ensure compliance and efficiency.

• Qualifications
• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
• 10+ years’ experience in QA within medical devices, with leadership experience.
• Strong knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820, and HSA requirements.
• Proven success in leading audits, inspections, and regulatory submissions.
• Excellent leadership, communication, and problem-solving skills.

This job posting is currently published for platform validation purposes during the pre-launch phase of MedicalHealthcareJobs.com, a platform developed to support the global Healthcare and Life Sciences recruitment ecosystem. Visitors may also stay updated with the latest industry news through our website while additional employers, recruiters, and opportunities are progressively onboarded.

Healthcare professionals are encouraged to sign up as a Jobseeker and start building their career profiles while we gradually onboard employers and recruiters to bring more opportunities to the platform.

Employers and recruitment partners may register for Employer Early Access Bonus 

Feedback and suggestions are welcome at [email protected].