[URGENT] Quality Process Engineer (Medical Device)

Location: Ho Chi Minh City
Salary Attractive salary
Specialization: Manufacturing & Industrial
Sub Specialization: Process Engineering, Quality Control/Quality Assurance, Quality Engineer
Contact: Ms. Thoa Nguyen

Position Title: Quality Engineer (VN)

Location: HoChiMinh City, Vietnam

 

Job Description

  1. Be responsible for quality control of the products manufactured by suppliers located in Vietnam. Responsibilities include but are not limited to new supplier process control set up, process audits, CAPAs/SCARs, supplier trainings, data collection and analysis, product testing, development of quality related methodology, etc.
  2. Ensure the suppliers are clear on Medline and International quality standards, processes and procedures for medical device manufacturing.
  3. Work with the suppliers to implement and maintain sufficient GMP and quality systems, including IQC, IPQC, FQC, good documentation practices, calibrations, maintenance, etc.
  4. Work with supplier to validate the production parameters and ensure the supplier properly document and verify these parameters once implemented.
  5. Work with Medline Shanghai and US team to determine appropriate testing parameters for the products to ensure limited failures in the field.
  6. Work closely with suppliers, the Shanghai office and the corporate office in the USA to lead product changes and improvements.
  7. Lead the root cause investigations and analysis for quality issues such as customer complaints and inspection rejections. Implement CAPAs based on root cause investigations to reduce complaint numbers.  Ensure that solutions to quality issues are properly implemented and upheld.
  8. Cooperate with multiple departments such as sourcing, logistics, QA/QC to drive new product/supplier development projects and meet with business prospects.

Qualifications:

  • B.S. Degree in Material Sciences, Mechanical Engineering, Automation, or other related science and engineering fields required.
  • Fluent in English is a must. Chinese is a plus.
  • 2+ years of experience in process control and quality control is in medical device industries will be highly preferable. Fresh graduates with desired background are welcome to apply.
  • Thorough knowledge with proven work experience in Plastic Molding is highly preferable.
  • Work Skills and Work Ethic:
    • Detail oriented with strong written and verbal communication, problem solving, and organizational skills.
    • Professional attitude with heightened sense of urgency, results oriented, 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: MS Word, MS Excel, Adobe and E-mail, AutoCAD or SolidWorks is a plus.