Create the future with us
Are you interested in making your mark? By joining our innovative team, you’ll have the opportunity to do exactly that. Agilis Robotics Limited is at the forefront of the industry, and we are always looking for talented professionals as we continue to grow. Check out our openings below to see if there’s a role that fits you.
Position title
Employment Type
Job Location
Quality Assurance ManagerFull-timeHong Kong
Quality Assurance Manager
Full-time
Hong Kong
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 Highlights
- Innovative medical devices development.
- Oversee QMS, change management, supplier audits and product release.
- Ensure quality and compliance of surgical robotic systems.
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.
Contacts
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 hr@agilisrobotics.com
