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Associate Quality Manager (Validation)

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Onsite
Onsite Location(s): 

Pulau, Penang, MY

Key Responsibilities

 

  • Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.
  • Read and interpret technical drawings, procedures, and protocols
  • Identify 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. May be responsible for working with process owner to bound product stops and document release criteria.
  • Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
  • Develops and implements Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
  • Leads Product/Process improvement efforts by identifying methods to capture quality metric data and by identifying & performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
  • Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Knowledgeable on Risk Management , BSEN 14971 requirements.
  • Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
  • Gives technical guidance to Quality Engineer I and II, Associate Quality Engineer, Technician and Inspection staff.
  • Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
  • Is familiar with the internal auditing process.
  • Responsible for the final Process Monitor Release for products prior to distribution.

About Us

As a global medical technology leader for more than 35 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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