苏州招聘

1)

Person with this position need to work to review whole ethylene oxide sterilization process and review batch records and assure all requirement are met before authorizing the products to ship.

(a) Work at supplier to perform daily check on ethylene oxide sterilization process including lab process to assure the practice will not have adverse effect on product quality.

(b) Work at supplier to review sterilization batch record to assure all requirements are met.

(c) Responsible for writing deviation reports, close deviation and tracking deviation.

(d) Follow-up with the supplier to make sure findings during daily check and batch records are corrected in time.

(e) Communicate with suppliers and Medline colleagues on daily basis.

2)

Support or perform validations.

(a) Coordinate validation schedule with suppliers and interface with Medline internal sterilization group.

(b) Write validation protocols.

(c) Execute the validation protocols.

(d) Write the reports to close the validation protocols.

3) Data Entry work to support the Quality department

1)

Other duties and projects as assigned.

1)

Medline Shanghai

2)

Medline American

1)

Suppliers.

1)

Bachelor degree

1)

Fluent both in written and verbal English. English level of CET 4. Strong verbal communication skills.

2)

Familiar with general office software.

3)

Extensive knowledge of FDA regulations, ASTM standards, QSR part 820, and ISO 13485.

4)

Good interpersonal and organization skills. Effective training skills.

5)

Strong time management skills. Ability to manage multiple projects.

6)

Excellent attendance record and ability to work overtime as needed.

1)

N/A

2)

N/A

1)

Must be enthusiastic in the job nature.

2)

Detail oriented.

3)

Good reporting and presentation skill

4)

Good interpersonal and communication skill.