Senior Quality Professional

15 hours ago


George Town, Penang, Malaysia Boston Scientific Full time

Boston Scientific is a leading medical technology company committed to delivering innovative solutions that transform lives. We are seeking an exceptional Senior Quality Professional to join our team.

The Senior Quality Professional will play a critical role in ensuring that our products meet the highest standards of quality and safety. They will work closely with cross-functional teams to implement and maintain effective quality systems, ensuring compliance with relevant regulations and industry standards.

Key Responsibilities:

  • Selects appropriate techniques for problem-solving and makes solid and consistent Engineering and Quality Assurance recommendations.
  • Reads and interprets technical drawings, procedures, and protocols.
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Identifies Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
  • Participates in Customer Complaints investigation for areas under their control.
  • Documents investigation findings in analysis report on GCS2.
  • Becomes a trainer for the Software related with complaints handling process (GCS2), as required.
  • Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
  • Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promoting awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the reference point.
  • Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
  • Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
  • Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
  • Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
  • Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
  • Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
  • Is familiar with the internal auditing process.

About Us:

We are a global medical technology leader for more than 40 years. Our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.



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