Boston Scientific Senior Quality Engineer APAC 

Malaysia, Penang 

513684103

Purpose Statement

• Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system
• Understands and complies with all regulations governing quality systems

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 products
• Identifies manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in the identification of primary root causes, and understanding corrective and preventative actions. May be responsible for working with the process owner to bound product stops and document release criteria
• Participates in customer complaints investigation for areas under their control
• Documents investigation findings in analysis reports on GCS2
• Becomes a trainer for the software related to the 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 the highest levels of professional QA engineering discipline and rigor
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final authority
• Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• 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, technicians, and inspection staff
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around these significant environmental impacts
• 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

Key Qualifications

• Bachelor's degree in Engineering/Science
• Minimum of 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, equipment repair/servicing, or calibration company
• Excellent influencing and communication skills
• Possesses analytical skills
• Good team player with a positive attitude to excel and work towards success
• Problem-solving skills
• Possesses leadership qualities to be able to lead the team in issues investigation