Executive

Job Requirement

A. Qualification Minimum Bachelor’s Degree in Science /Chemical Engineering/ Mechanical Engineering/Chemistry or equivalent.

B. Experience · Minimum 3-5 years’ working experience in related field. · Knowledge and experience in medical device regulations, validation, audit, risk management, ISO 9001 and ISO 13485 quality management systems, cGMP and FDA in a regulated environment.

C. Other Personal Capabilities · Good discipline and attitude, proactive and good initiatives. · Good written and oral communication skills · Good interpersonal skills. · Good analytical, problem-solving skills and decision making. · Good observant, truthful, sincere and honest. · Ability to manage, result orientated, have good time management and resourceful. · Ability to work independently with minimum supervision. · Ability to exceptional listening, and presentation skills. · Ability to work well with people at all levels of the organization. · Strong computer skills are preferred.

Job Responsibility

1. Responsible for preparation of all Quality Document associated with the manufacture of medical devices to ensure compliance with ISO 13485, ISO 9001, cGMP, FDA and MDR guidelines.
2. Interface with other departments to compile and determine the required content of quality document for preparation of production Technical File, product specification, device master record and other Quality document.
3. New artwork packaging design review to comply all applicable with EC Council Directives, FDA and other international regulations.
4. Assists in establishing, reviewing and / or updating company’s Procedures and Work Instructions.
5. Assists in the preparation, coordinating and handling the internal and external audits.
6. Assists in compiling data and quality trends for management reviews.
7. Assists in compiling and providing the documentation on product registration and any other Marketing request.
8. To arrange, preparation and document the product shelf life study in accordance to the international standards.
9. To observe the company policy.
10. To follow the company safety rules and regulations in daily operation.
11. Other assigned duties as required by his/her superior.