深圳招聘

职位描述：
Job summary:
Develop and implement quality system together with quality control programs to achieve the objectives of high quality of products and quality system, work for regulatory affairs for medical devices. Assures consistent quality of production by developing and enforcing good manufacturing practice (GMP) systems; validating processes; providing documentation; managing staff.

Responsibilities:
1. Establish and optimize the inspection standard of incoming and in process materials and monitor the performance, guide MRB team members for any non-conformity handling.
2. Create and execute quality development plan, continuously to improve the quality
3. Make preventative action plans for frequent quality problems to improve materials reliability, address specific quality issues and drive root cause analysis and corrective/preventive measures.
4. Coordinate and follow up customer complaint.
5. Actively involved into new project and work closely with production, engineering & HR to optimize the manpower structure and improve quality team's efficiency.
6. Lead and develop internal quality management team, optimize the process flow in quality management area, comply with company business expansion.
7. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits;
8. Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; identifying and resolving problems; determining system improvements; implementing change.
9. Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits
10. Validates quality processes by establishing product specifications and quality attributes; determining operational and performance qualification; writing and updating quality assurance procedures.
11. Follow internal /external audit.
12. Quality and Regulatory affairs communicate window between BV team and CN team;
13. Deal with other assignments assigned by superior.
Qualification:
1. Bachelor degree or above
2. Good communication, fluent English (Oral, write and aural). At least CET-6 or equivalent level, the working language is English.
3. Have at least 3 years work experience on Quality & Regulatory affairs of Medical Device Line
4. Be familiar with ISO 13485, MDD and cGMP;
5. Be familiar with statistical tools
6. Be familiar with sterility medical device and familiar with corresponding standards;
7. Be familiar with Regulatory requirements of Medical Device of CFDA
8. Strong attention to detail
9. Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities 举报 分享

EPG is an ISO13485 certified Medical Device manufacturer involved in the design & development, manufacturing, sales and distribution of needle-free devices (InsuJet) for the administration of medicinal products.We started in China in 2010 and our team continues to grow, welcome to join us.