Quality Engineer III: Process Validation & CAPA Expert

Boston Scientific; Penang; Presencial; MYR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Boston Scientific in Penang, Malaysia is seeking a Quality Engineer to identify manufacturing defects, analyze results, and drive improvements in product quality. You will interpret drawings, support CAPAs and investigations, and collaborate with cross-functional teams to ensure regulatory compliance.

You will contribute to validating processes, reviewing reports, and mentoring staff while promoting best industry practices in a regulated medical device environment.

Formación

• Bachelor’s Degree in Engineering, Technology, or a related Science discipline.
• Minimum 5 years of relevant experience in a regulated industry, preferably within the medical device industry.
• Experience in running and reviewing nonconforming event risk assessments and investigations.
• Experience working in quality engineering, process validation, and quality system compliance.
• Strong analytical and problem-solving skills with the ability to support quality and operational excellence initiatives.

Responsabilidades

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• 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.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Document investigation findings in analysis report on GCS2.
• Continually seeks to drive improvements in product and process quality.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices.
• 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.
• Supports other functional areas during validation activities.
• Knowledgeable on Risk Management and EN 14971 requirements.
• Compiles and analyses data to establish technical specifications and performance standards.
• May participate in new product/technology transfer for compliance with internal and regulatory requirements.
• Uses Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Ensures laboratory equipment is compliant for analysis activities.
• Gives technical guidance to Associate Quality Engineer and Inspection staff.

Conocimientos

Root Cause Analysis

Statistical Analysis

CAPA/NCEP/FMI experience

Quality Risk Management

Cross-functional collaboration

Strong communication

Problem solving

Educación

Bachelor’s Degree in Engineering, Technology, or related Science

Herramientas

Excel

Minitab

Descripción del empleo

Boston Scientific in Penang, Malaysia is seeking a Quality Engineer to identify manufacturing defects, analyze results, and drive improvements in product quality. You will interpret drawings, support CAPAs and investigations, and collaborate with cross-functional teams to ensure regulatory compliance.

You will contribute to validating processes, reviewing reports, and mentoring staff while promoting best industry practices in a regulated medical device environment.