Quality Engineer

2 weeks ago


Kuala Lumpur, Kuala Lumpur, Malaysia Medline Industries, LP Full time

Direct message the job poster from Medline Industries, LP

Responsibilities
  • 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 teams (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 the 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 suppliers 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, Material, Industrial Engineering, or Medical Device related engineering field required.
  • 3+ years of engineering 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 in PC skills: AutoCAD or SolidWorks, MS Word, MS Excel, Adobe, and Email.
  • Available to travel frequently.
  • Excellent English speaking, reading, and writing skills.
  • Capable of handling special projects as directed by Managers.
Seniority Level

Entry level

Employment Type

Contract

Job Function

Quality Engineering

Industries

Medical Equipment Manufacturing

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