杭州招聘

行业：美国著名医疗器械公司

Responsibilities

1. Act as the plant Management Representative focusing onorthopedic instrumentation manufacturing

2. Responsible for ensuring compliance with FDA, ISO 13485, the Medical Device Directive and the China Medical Device Regulations.

1. Knowledge of product complaint handling, including Medical Device Reporting requirements and their impact on internal investigations.

2. Work with manufacturing to determine manufacturing process requirements, process design and process validation.

3. Ability to write Technical Documents such as, Validation Protocols, Test Procedures, and Test Reports in a concise and clear manner

4. Coordinate problem resolution with manufacturing, engineering, customer service and other areas.

5. Planning and executing internal and external quality systems auditing as scheduled and/or required.

6. Internal and external audit escort for regulatory bodies (i.e., FDA, Notified Body, CFDA inspection, etc.).

7. Support company continuous improvement programs. Implement new quality systems and techniques as required to meet company needs and to keep abreast of the latest developments in the field of Quality Assurance / Engineering.

8. Provide technical support to the R&D, Materials and Manufacturing departments during the design phase, transfer, and production as needed.

Qualifications

1. Must have at minimum 5 years’ experience in instrumentation manufacturing industry. Orthopedic instrumentation quality experience is plus.3-5 years of experience in medical device industry.

2. Must have at least 5 years manager or supervisor experience and have at minimum 5 years project management roles.

3. BS in engineering field and 8 years related quality engineering experience

4. Excellent technical writing skill and ability to communicate well (both written and verbal)

5. Excellent analytical thinking skills and ability to effectively manage multiple projects and priorities

6. Proven ability to lead and work effectively in cross-functional teams

7. Strong organization and time management skills

8. Excellent communication skills

China Recruiter, 作为国内领先的专注工业招聘的猎头公司,我们专注于汽车、机械、设备、航空和海事设备、电子和电气等领域，是跨国工业企业和世界500强公司在中国招聘的合作伙伴；目前，我们的客户来自美国,德国,英国,法国,和瑞典,意大利和加拿大，分布于北京、上海、广州、深圳、香港、天津、沈阳、大连、青岛、济南、廊坊、潍坊、西安、银川、四川泸州、成都、重庆、武汉、湖北十堰、河南信阳、苏州、无锡、南京、太仓、徐州、吴江、芜湖、合肥、无锡、常州、东莞、江门、中山、珠海等大中城市；我们通过与澳洲、新加坡的合作伙伴来帮助我们的客户。
China Recruiter is the leading provider of executive search services. With focus on china, the most fast-growing country around the world, we cooperate closely with multinationals, local giants and high calibers to craft successful human capital strategies and solutions—offer creative suggestions to clients with leadership needs meanwhile provide expertise to professionals to achieve career excellence
With a distinctive vision, China Recruiter is dedicated to the fields where specific engineering and science capabilities required, under which we believe engineering and science capabilities and their innovation are the engine to drive companies forward, no matter these companies are multinational or local, big or small, existing or start-up. Underpinning this vision is our success, in a rapidly increasing way, more than 90% of our business flows from existing clients, ranging across industries, from North, East, Central, South China as well as Hong Kong
Clients and professionals are often amazed at our multi-win solutions generated by the blend of art and science, the art of (individual or collective) judgment combined with the science of our process and systems, which roots in our culture. At china Recruiter, we embrace and award team work, collaboration, knowledge sharing, creation, innovation as well as lasting study, we invest heavily in training and development to continue these spirit; we strive to be the most specialized and the best, rather than the biggest or the most visible, this philosophy has cultivated our long-term commitment to clients, professionals and our people, no matter it is a prosperous or a slump economy, we stand by as always.
At China Recruiter, we treasure people as the most important assets, here you can enjoy the work, improve yourself and realize your ambition.
Come on! Join with us now!