Job Summary:

Innovative medical devices development.

Oversee QMS, change management, supplier audits and product release.

Ensure quality and compliance of surgical robotic systems.

Job Highlights:

5-day work week.

Collaborative team culture valuing creativity, problem-solving, and learning.

Opportunity to work in an impactful, innovative, and fast-paced environment.

Job Responsibilities:

Quality management system 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

Job Requirements:

Professional fluency in spoken and written English and Cantonese (Mandarin is a significant plus).

Bachelor’s degree or above in a related field.

Preferred at least 5 years of experience in medical device QA.

Certified Quality professional – Six sigma black belt, CQE, CQA, CQM, or equivalent or medical QMS internal auditor are 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 China or overseas.

Candidates with less experience will be considered as QA Specialists.

We offer an attractive remuneration package including competitive salary, 5-day work and annual leave.

Interested parties please send full resume with present and expected salary to Human Resources Department.