Quality Assurance Manager

15 hours ago


George Town, Penang, Malaysia Boston Scientific Full time

At Boston Scientific, we are dedicated to transforming lives through innovative medical solutions. We are currently seeking a highly skilled Quality Assurance Manager to join our team.

The Quality Assurance Manager will be responsible for demonstrating commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. They will understand and comply with all regulations governing the quality systems and ensure that their direct reports are aware of their commitment to patient safety and product quality.

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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