质量工程师 (药剂类方向) (MJ000080)

Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.

Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable -quality.

Work with other functional team (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.

Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.

Be responsible for projects with vendors from a quality perspective, more specifically, on product design change, quality performance improvement, and monitoring quality performance on critical products.

Work with Suppliers and Company corporate office in US to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.

Work with suppliers and Company QC team in China to reduce product rejections.

Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.

Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.

QUALIFICATIONS

B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.

3+ years of engineer experience, project management is preferred

Understanding of quality system requirements (ISO 13485 or ISO

9001)

Ability to read and interpret product specifications and drawings

Detail oriented with strong written and verbal communication, problem solving, and organizational skills

Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.

Ability to effectively recognize and suggest improvements for finished products, processes and documentation practices to suppliers, managers, and coworkers.

Proficiency of PC skills:

AutoCAD or SolidWorks, MS Word, MS Excel, Adobe and E-mail

Available to travel frequently.

Excellent English speaking, reading and writing skills.

Capable of handling special projects as directed by Managers.