Quality Assurance Manager

About the role

Build quality management system and monitor quality issues of the product in both development and production process. Oversee QMS, change management, supplier audits and product release.

Key responsibilities

• Build quality management system and monitor quality issues of the product in both development and production process
• QMS setup, implementation, and supporting offsite facilities to align medical industrial best practices
• Lead and manage customer inquiries, incidents investigation, complaint follow-up, root cause analysis and change management
• Perform product design review, risk analysis, validation, or solutions on any issues related to the product/parts, process, equipment, or tools as appropriate
• Lead suppliers auditing and product release activities
• Coach Company stakeholders to fulfil the medical QMS and regulatory requirements
• Ad hoc assignment related to new medical device regulations, customer requirements, corporate initiatives, or strategic programs

About you

• Professional fluency in spoken and written English and Cantonese (Mandarin is a significant plus)
• Bachelor's degree or above in a related field
• At least 5 years of experience in medical device QA (preferred)
• Certified Quality professional – Six sigma black belt, CQE, CQA, CQM, or equivalent or medical QMS internal auditor (preferred)
• Experience in QMS setup, implementation, audit, and certification to satisfy ISO 13485, MDSAP and China NMPA requirements
• Strong technical background with the ability to understand engineering concepts
• Strong team spirit and ability to work under pressure
• Good problem solving, interpersonal skills, and able to work effectively within a team in a fast-paced changing environment
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization and external parties
• Willing to travel to production facilities and vendors in Mainland or overseas

Benefits

• Competitive salary
• 5-day work week
• Annual leave