Senior Quality RI FG Engineer

Boston Scientific; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, is seeking an experienced Quality Engineer to ensure product quality across the manufacturing and testing environment. You will lead IQA and OQ efforts, review non-conformances, and drive CAPA investigations while collaborating with Manufacturing, Engineering and Suppliers to resolve complex issues.

The role requires an undergraduate science degree and at least five years in regulated QA, with strong data analysis, risk assessment, and knowledge of GMP/ISO

Qualifications

• Undergraduate degree in Science, Material, or related discipline.
• Minimum 5 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience in IQA and OQ activities and product release.
• Experience supporting material issue management and release decisions.
• Knowledge of GMP/ISO and regulatory requirements.

Responsibilities

• Identify and resolve complex exceptions to work assignments.
• Summarize, analyze, and draw conclusions from test results and process findings.
• Read and interpret technical drawings, procedures, and protocols.
• Disposition non-conforming material and support root cause investigations.
• Dispositions decisions related to product quality and release criteria.
• Participate in customer complaints investigations and document findings.
• Drive CAPA, NCEP, and FMEA activities and improvements.
• Mentor and guide Associates in QA activities and inspection staff.

Skills

Stakeholder mgmt

IQA experience

OQ validation

Product release

Root cause analysis

Data-driven decisions

SAP knowledge

Cross-functional collab

Risk assessment

Statistical analysis

Manufacturing liaison

Education

BSc in Science or related

Tools

SAP

Job description

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• 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.
• Perform incoming quality inspection activities for raw materials and outgoing quality inspection activities for finished goods.
• Conduct inspection and evaluation activities in the quality laboratory to ensure compliance with established specifications and quality standards.
• Accountable for product release decisions and ensuring released products meet quality and regulatory requirements.
• Support material issue investigations, containment actions, and resolution activities to maintain product quality and compliance.
• Partner closely with Manufacturing, Engineering, Materials, Suppliers, and other stakeholders to drive issue resolution and continuous improvement.
• Provide effective stakeholder management and timely communication to ensure alignment, rapid decision-making, and minimal operational disruption.

Requirements

• Undergraduate Degree in Science, Material Engineering, or a related discipline.
• Minimum 5 years of experience in Quality Engineering within a regulated manufacturing environment.
• Experience in Incoming Quality Assurance (IQA) and Outgoing Quality Inspection.
• Experience in equipment qualification and test method validation.
• Experience supporting material issue management and product release activities.

Required Skills

• Strong stakeholder management and communication skills.
• Incoming Quality Inspection (raw materials) and Finished Goods (FG) Quality Inspection.
• Product release accountability and decision-making.
• Equipment and Test Method Validation.
• Strong problem-solving and root cause analysis skills.
• Analytical thinking and data-driven decision making.
• SAP knowledge for quality and material management.
• Cross-functional collaboration.
• Risk assessment and nonconforming material investigation.
• Statistical analysis and quality improvement tools.
• Ability to work effectively with Manufacturing, Engineering, Materials, and Quality stakeholders.

About Us

As a global medical technology leader for more than 45 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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