Quality Assurance Manager

Precision Robotics (Hong Kong) (PRHK) Limited is an innovative robotic company which aims to

advance surgical robotics with novel intelligent surgical technologies. Precision Robotics Limited

is a spun‐off company from Imperial College London, UK. As a technology start‐up company,

PRHK is a very fast‐growing company with its head quarter based in the Hong Kong Science and

Technology Park, and offices in Shanghai and Suzhou. Based on many years of cutting‐edge world

leading surgical robotics and AI research, PRHK was set up with targets on translating the

academic research outcomes into clinical products enabling the next major transformation of

robotic surgeries leading to better patient outcomes.

We are currently recruiting for the following position:

Quality Assurance Manager (QAM)– a quality assurance manager will be responsible for

maintaining and extending the company quality assurance system ISO13485 to cover the existing

and new product lines. In addition, the QAM shall lead, coordinate, and maintain the regulatory

related applications and affairs, such as CE Mark, FDA510k and China NMPA regulatory approval

and reporting processes. This position will take the overall responsibility in assuring that the

company’s Hong Kong and China Quality and safety system requirements are effectively

established, implemented and maintained in compliance with CGMP’s and other regulatory

requirements.

Tasks/responsibilities:

 Overall responsibility for assuring that the company’s Hong Kong and China sites comply

with all relevant regulations and standards;

 Manage and maintain the certification of ISO 13485, CE Mark, FDA510k, NMPA, etc., of

the products of the company;

 Direct quality personnel in the establishing, training, implementing and monitoring of

quality and safety procedures;

 Facilitate customer and supplier matters relating to the company’s quality system;

 Manage the suppliers of the company and ensure that the suppliers are adhered to the

company’s quality and safety guidelines;

 Develop the Quality and Safety System procedures to ensure company’s overall Quality

performance and its compliance to regulations and standards;

 Assure that all employees of company are trained with good understanding of all

current regulatory and standard requirements, and ensure that the employees are up to

date on any recent updates on regulations and standards;

 Host and assist external medical device related audits. Document the audit results,

report and advice the company’s executive management regarding all finding,

observations and any resulting Corrective Actions;

 Conduct internal quality and safety audits and trainings at regular intervals to assure

that the quality and safety system complies with the established Quality and safety

system requirements;

 Report to the executive management at defined intervals on the company’s Quality

System performance to ensure its effectiveness;

 Manage the coordination, review, investigation and documentation of complaints

relating to the company’s product, and reporting to the respective regulatory bodies as

required;

 Chair Quality and Safety System Management meetings which gather and report on the

company’s Product Quality and Safety System;

 Lead the development of the Software Validation Plan and test cases

 Responsible for all other duties as assigned;

Your background and profile:

 Possess a bachelor’s degree or above in science, engineering, medical technology or

related disciplines, with at least 8‐year post‐qualification experience and at least 3 years

in quality assurance management role in the field of medical device or related fields.

 With IP experience is a significant advantage

 Proven leadership skills

 Supervisory and management experience

 Excellent communication and interpersonal skills

 Proficiency in written and spoken English. Cantonese and Mandarin are required

 Experience with ISO 13485, FDA510, NMPA, CE Mark etc., preferred

 Travel in China and internationally