Quality Assurance Lead

2 weeks ago


George Town, Penang, Malaysia Boston Scientific Full time

Company Overview

Boston Scientific is a leading medical device company with over 40 years of experience in solving healthcare challenges. Our mission is to advance science for life by developing innovative medical solutions that improve patient lives and create value for our customers.

We are committed to applying our values to everything we do, both as a global business and as a corporate citizen. Our responsibility extends beyond delivering exceptional products to supporting the communities we serve.

Job Description

  • Senior Quality Engineer (APAC): We are seeking an experienced Senior Quality Engineer to join our team in APAC. As a key member of our quality assurance team, you will be responsible for ensuring the highest levels of quality engineering discipline and rigor within our organization.
  • Key Responsibilities:
    • Selecting appropriate techniques for problem-solving and making solid Engineering and Quality Assurance recommendations.
    • Reading and interpreting technical drawings, procedures, and protocols.
    • Responsible for product quality, including dispositioning non-conforming products.
    • Identifying manufacturing process defects by dispositioning non-conforming material and understanding corrective actions.
    • Participating in customer complaints investigation.
    • Documenting investigation findings in analysis reports on GCS2.
    • Becoming a trainer for software related to complaints handling process (GCS2).
    • Checking and providing support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

Required Skills and Qualifications

  • Bachelor's degree in Engineering/Science.
  • Minimum 7 years of working experience in quality system regulated organizations and familiarity with ISO 9001 and/or ISO 13485.
  • Experience in Quality/Engineering roles and possess working experience in a medical equipment manufacturing or calibration company.
  • Excellent influencing and communication skills.
  • Possesses analytical skills.
  • Good team player with a positive attitude to excel and work towards success.

About Boston Scientific

We have a deep caring for human life and are united by a shared purpose to solve the challenges that matter most. Our commitment to advancing science for life drives us to develop innovative medical solutions that improve patient lives and create value for our customers.



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