苏州招聘

Quality Assurance Specialist (质量保证专员)-Medical &Biopharm

Position Objective
The incumbent shall be responsible for the management of Asia’s customer complaints for Biopharm and Medical, mainly for China’s customers. This person is to support China customer’s request for Quality related information, including vendor’s questionnaire and also assist to help local operations to be compliant to local Medical regulatory, as well as corporate Quality Management System requirements.

Main Responsibility
1. POR management of Medical and Biopharm customers (65%)
2. Work with supply chain to manage Quality Hold/ Recall initiated by overseas Manufacturing sites or Corporate/ Regional offices. (5%)
3. Sales Enquires on Quality certificates or other information about manufacturing sites (5%)
4. Support Regional/ Corporate Quality Management System and other Medical Regulatory requirements, as well local QMS specific to Medical and Biopharm requirements (10%)
5. Conduct internal/ external audits (5%)
6. Working with China business leaders (Medical and Biopharm) on POR chart trending and updates (10%)

Minimum Qualifications:
1. Degree in Engineering
2. 2 – 5 year’s experience in Life Sciences Industry
3. Preferred experience in Quality Assurance department of a manufacturing plant.
4. Knowledge of ISO 9001, ISO 13485
5. Good written and spoken English

Position Competencies
1. Ability to analyze and perform simple investigation
2. Knowledge of general processes in a manufacturing plant
3. Good time management
4. Ability to multi-task
5. Resourceful in finding information

Minimum Qualifications: (List the minimum qualifications and experience this position requires. Only list those areas that are essential to this position. Be as specific as possible, i.e. Bachelor’s degree in Chemical Engineering, 5 – 7 years relevant work experience).
1. Degree in Engineering
2. 2 – 5 year’s experience in Life Sciences Industry
3. Preferred experience in Quality Assurance department of a manufacturing plant.
4. Knowledge of ISO 9001, ISO 13485
5. Good written and spoken English

Position Competencies (include behavioral characteristics and leadership capabilities)
1. Ability to analyze and perform simple investigation
2. Knowledge of general processes in a manufacturing plant
3. Good time management
4. Ability to multi-task
5. Resourceful in finding information

Other Requirements (include culture, fit and values)
1. To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures. (Mandatory- Do not Remove)
2. Ability to work well with people of various background, of global profile
3. Ability to travel up upon request.