南京招聘

Job Title: Senior Quality Engineer

Location: Shanghai

Report to: Associate Quality Assurance Director

Roles and Responsibilities:

1. Ensure design transfer to manufacturing successfully by working together with design, manufacturing, sourcing etc.

2. Conduct finish good release on behalf of legal manufacturer

3. Ensure production comply with ISO 13485, local GMP or oversea GMP inspection regulation, NMPA registration QMS requirements, act as SME in production quality management

4. Perform periodical manufacturing process audit to ensure product and production process conformity.

5. Monitor the product and process quality performance with supplier quality team. Provides analytical and statistical information to assure quality products and services.

6. Support post-market activities, such as complaint investigation in production site.

7. Support other company initiatives related to medical device production quality system, such as repair center.

Qualification：
Over 3-5 years working experience of QA position in MD manufacturing area
Design transfer and NMPA registration QMS audit experience are preferred Mechanical background

Fluent in English

Experience of MAH project is a plus

Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.
 
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
?    Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
?    Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
?    Sports Medicine - minimally invasive surgery of the joint
?    Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .