Quality Engineer III

Boston Scientific; Penang; On-site; MYR 70,000 - 120,000; Full time

Job summary

Boston Scientific in Penang, Malaysia is seeking an experienced Quality Engineer to lead quality improvements across manufacturing and test processes. You will analyze data, support CAPA investigations, and ensure compliance with QSR, ISO, and medical device regulatory requirements while guiding cross-functional teams.

You will review validation protocols, participate in new product transfers, and drive Six Sigma and Lean initiatives to prevent defects and enhance product quality.

Qualifications

• Bachelor's degree or higher in engineering.
• Minimum 6 years of experience in Operations Quality, medical device industry preferred.
• Strong knowledge of quality systems, regulatory requirements, and quality engineering principles.
• Experience in regulated manufacturing environments.
• Strong analytical and decision-making skills; able to resolve complex quality issues.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions from test results or process findings.
• Read and interpret technical drawings, procedures, and protocols.
• Identify manufacturing defects and disposition non-conforming material; assist in root-cause analysis and corrective actions.
• Make decisions related to product quality, including disposition of non-conforming product.

Skills

Problem solving

Root cause analysis

CAPA

Quality management

Data analysis

Six Sigma/Lean

Regulatory knowledge

Communication

Team mentoring

Cross-functional collaboration

Education

Bachelor's degree or higher in Engineering

Job description

Key Responsibilities

• 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. May be responsible for working with process owner to bound product stops and document release criteria.
• 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.
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• 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, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decision.
• 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.
• Compiles and analyzes operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
• Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• 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.

Requirements

• Bachelor's Degree or higher, preferably in an Engineering discipline.
• Minimum 6 years of experience in Operations Quality; prior experience in the medical device industry is preferred.
• Strong knowledge of quality systems, regulatory requirements, and quality engineering principles.
• Experience working in a regulated manufacturing environment.
• Strong analytical and decision-making skills with the ability to resolve complex quality issues.
• Ability to work independently and effectively in a cross-functional environment.

Required Skills

• Effective problem-solving and root cause analysis skills.
• Product risk assessment and risk management.
• Data analysis and statistical analysis.
• CAPA, non-conformance, and quality investigation management.
• Process validation and validation documentation.
• Six Sigma and Lean methodologies.
• Knowledge of QSR, ISO, and medical device regulatory requirements.
• Customer complaint investigation and complaint handling processes.
• Technical report writing and documentation.
• Cross-functional collaboration and stakeholder management.
• Strong communication and presentation skills.
• Experience in people management is an added advantage.