Director, Quality Assurance APAC

Job Overview

Hologic, Inc. is seeking a Director, Quality Assurance APAC to lead and manage quality assurance operations across the Asia-Pacific region. This role is crucial in ensuring regulatory compliance and maintaining high standards for groundbreaking medical technology products, contributing to healthier lives everywhere, every day.

Company Overview

Hologic, Inc. is an innovative medical technology company dedicated to enabling healthier lives, with a special focus on advancing women’s health and well-being. They develop groundbreaking products and services in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions. The company’s growth is powered by its employees’ talent and dedication to science-based certainty, driving a global presence and a pipeline that addresses unmet health needs.

Quick Details

• Salary Range: Market Competitive
• Job Type: Full-time
• Qualifications: None / Open to all applicants
• Experience: 10 Year+

Key Responsibilities

• Lead and manage all Quality Assurance activities and teams across the APAC region.
• Develop, implement, and maintain robust Quality Management Systems (QMS) compliant with international standards and regional regulations.
• Ensure regulatory compliance for all medical devices and diagnostic products within APAC markets.
• Oversee internal and external quality audits, driving effective corrective and preventive actions.
• Collaborate with R&D, manufacturing, and commercial teams to integrate quality throughout the product lifecycle.
• Monitor and report on key quality metrics, identifying areas for continuous improvement and innovation.

Requirements

• Extensive leadership experience (10+ years) in Quality Assurance within the medical device or pharmaceutical industry.
• In-depth knowledge of APAC regulatory requirements (e.g., TGA, HSA, NMPA) and international quality standards (e.g., ISO 13485, FDA QSR).
• Proven ability to develop, implement, and manage complex Quality Management Systems.
• Strong leadership skills with experience managing diverse, cross-cultural teams.
• Exceptional communication, negotiation, and problem-solving abilities.
• Bachelor’s degree in a relevant scientific or engineering discipline; Master’s preferred.

Benefits

• Opportunity to lead critical quality initiatives in a globally recognized medical technology company.
• Contribute directly to advancing women’s health and well-being through innovative products.
• Competitive compensation package and comprehensive employee benefits.
• Opportunities for professional development and career advancement within a growing organization.
• Work in a collaborative, purpose-driven environment committed to scientific excellence.
• Engage with cutting-edge medical technologies and a diverse international team.