苏州招聘

Main Responsibilities

Setup the quality control program from product pilot to serial production lots.

Be knowledgeable about the plant equipment and environment for optimum performance in equipment and environmental cleaning. Liaise with production personnel to carry out the validation and routine monitoring for environment and critical systems (air system, water system, etc.)

Execute the qualification/ validation, routine monitoring and maintenance for lab equipment.

Liaise with serialization vendor to carry out the product sterilization validation.

Establish quality specification, SOP, and working instruction, according to good laboratory practice (GLP), along with respect to corporate and local quality requirement.

Train and qualify the process inspector all quality control activities, immediately report all observations of GMP non-conformances during the routine monitoring.

Conduct the final Product release and routine product quality sampling test (Bio-burden test, sterility test, pyrogen test, particulate matter counting, etc.)

Coordinate the quality deviations handling, change controls and complaint investigation.

Analysis the lab quality trend(Defect Rate, data trending, etc.) on an ongoing basis, improve the product quality performance level with implementation of continuous improvement tools.

Maintain and ensure safe working conditions.

Accomplish other duties as assigned.

Qualification

Education

College or Bachelor degree, majored in science of Microbiology, Biochemistry, pharmaceutical, food etc.

Woke Experience

Minimum of 3 years working experience in microbiological laboratory, above 3 years in EU/US company is preferred.

Food, dairy or pharmaceutical experience is preferred.

At least 2 years working experience in GMP environment of medical industry is preferred.

Language

Good English communication both in oral and written.

Skill

Familiar with ISO9001, GMP, GLP and validation.

Be familiar with micro lab internal quality controls.

Familiar with quality control statistic tools, SPC, MSA, GR&R etc.

Good computer and software skills.

Attitude

Self-motivated, initiative and able to work under pressure.

Great Systematic& Logical thinking.

Team work spirit. Good communication and coordination skills.

MAQUET is a world famous medical treatment equipments and ，system engineering company with more than 170 years history, which headquartered in Germany. It belongs to the publicly-listed Swedish group of companies Getinge AB and has under it three specialty divisions for Surgical Workplaces, Critical Care, Cardiopulmonary. As a global market leader and one of largest suppliers of Emergency Rooms, Operating Rooms and Intensive Care Units, MAQUET is always devoting to perfect the quality, efficiency of medical treatment and workflow-optimized clinical infrastructure for providing worldwide hospitals with best quality system engineering and line products. The MAQUET organization is to be found all over the world, with 36 direct subsidiaries on all the continents and with over 200 specialist distributors and partner companies in sales and service representing MAQUET.

MAQUET (Suzhou) Co., Ltd was established in April of 2007. As the only production bases outside Europe, MAQUET (Suzhou) upholds the concept of quality enhancement and high efficiency all the time. Benefiting form the successful experience of operations in German and French factory, we supply the global market with series of best-quality products.

We attach great importance to the employees self growth and development, valuing the diversity of individuals, ideas and what they bring to the workplace. At MAQUET, with favourable working and personal development environment, we offer all of the employees with large range of career opportunity and better training (domestic or overseas training) opportunities.

The dynamic development of MAQUET and the multiplicity of our fields of business offer many career challenges. To further strengthen our team, we are looking for co-workers dedicated to enhancing our success. You are warmly welcomed to join us!
　
总部位于德国的MAQUET 是一家拥有170多年悠久历史的医疗设备和系统工程公司，隶属瑞典GETINGE AB集团。集团下设外科系统部、心脏外科部、重症护理部，所辖品牌均为行业领导者。作为全球手术室﹑ICU医疗工程和设备最大供应商之一，MAQUET一直致力于完善医学治疗的质量、效果和工作流程，为全球医院的手术室、心胸外科、ICU提供最具品质的系统工程和系列产品。至今，MAQUET在全球已设有三十六个直属销售机构 ，超过两百个分销商和服务机构。

迈柯唯医疗设备（苏州）有限公司于2007年4月正式成立。作为集团外科系统部在欧洲本土以外的唯一的生产基地，迈柯唯苏州始终坚持高品质、高效率的制造理念，同时借鉴公司德国和法国工厂的丰富经验，向全球市场提供顶尖的医疗设备产品。

公司注重员工的成长及培养，珍惜每个雇员的多样性、观点以及他们为公司所创造的价值。公司拥有良好的工作和个人发展环境，并提供广阔的职业生涯和优良的国内/国外培训机会。