Quality Specialist (1 Year Contract)

About the role

Edwards Lifesciences is seeking a Quality Specialist on a 1‑year contract to support product quality and regulatory compliance in Hong Kong. You will work closely with local supply chain, business units and third‑party logistics (3PL) partners to ensure that all medical devices meet the highest standards before reaching patients.

Key responsibilities

• Manage local product quality control and 3PL oversight to guarantee traceability and compliance.
• Monitor pre‑market and post‑market quality processes, flagging and escalating potential risks.
• Track 3PL performance, identify gaps and drive continuous improvement initiatives.
• Maintain and enhance product inspection and release procedures to prevent defective releases.
• Coordinate local quality holds and collaborate with supply chain, business, and regulatory affairs.
• Implement change‑control activities with 3PL and internal stakeholders.
• Oversee quality system performance in Hong Kong, ensuring achievement of quality objectives and alignment with regulatory updates.
• Support complaint handling, customer inquiries and field corrective actions.
• Promote a strong quality culture through training, awareness programs and stakeholder engagement.

Required profile

• Bachelor’s degree with at least 2 years of QA experience in the medical‑device industry.
• Strong communication skills in English and Mandarin.
• Meticulous attention to detail and a proactive mindset for identifying improvement opportunities.

Required skills

• Knowledge of medical‑device quality standards and regulatory requirements (e.g., Hong Kong regulations).
• Experience with change‑control processes and quality system management.
• Ability to work with third‑party logistics providers and cross‑functional teams.