Senior Quality RI FG Engineer

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 90,000 - 140,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Penang seeks a Senior Quality Engineer to lead complex quality activities in a regulated manufacturing environment, focusing on product release, IQA/IQC, CAPA investigations and validation of equipment and test methods.

You will work with Manufacturing, Engineering and QA teams to drive improvements, ensure conformity to QSR/ISO standards, and uphold high standards for process validation and risk management.

Qualifications

• 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.
• Strong stakeholder management and communication skills.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results.
• Read and interpret technical drawings, procedures, and protocols.
• Dispositions non-conforming material and identifies root causes; supports CAPAs and changes.
• Ensures product quality decisions and release criteria are met.
• Participates in investigations for customer complaints and quality events.
• Supports validation protocols and reports; collaborates with multiple functions.

Skills

Stakeholder management

Analytical thinking

Statistical analysis

Problem solving

Cross-functional

SAP knowledge

Drawing interpretation

Risk assessment

Equipment qualification

Test method validation

Education

Bachelor's degree in Science or related

Tools

SAP

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. 4.2 View all jobs

• 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 analyses 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.

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 analyses 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.
• Engineering drawing interpretation.
• 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.

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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Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.