Senior Quality Engineer (Seismiq)

Boston Scientific Gruppe; Penang; On-site; MYR 60,000 - 100,000; Full time

Job summary

Boston Scientific in Penang seeks a Quality Engineer to support QA activities in a regulated medical device context. You will review processes, approve nonconforming material, and drive CAPA investigations to safeguard patient safety and product quality.

Collaborating with cross-functional teams, you will validate changes and maintain compliance with ISO 13485 and related standards. Strong analytical and documentation skills are essential.

Qualifications

• Bachelor's Degree in Engineering, Technology, or related Science.
• 4–5 years of experience in a regulated industry, preferably medical device.
• Experience reviewing nonconforming event risk assessments and investigations.
• Strong understanding of quality systems and regulatory requirements.
• Strong analytical mindset with proven problem-solving capability.

Responsibilities

• Selects techniques for problem solving and provides QA recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Decides on product quality disposition for non-conforming material.
• Identify manufacturing defects and support CAPA investigations.
• Participate in Customer Complaints investigations within scope.
• Document investigation findings and report in system.
• Provide training related to complaints handling (GCS2) as required.
• Support CAPAs, NCEP, and Failure Mode Investigations execution and inquiry.
• Promote QA discipline and regulatory compliance within the team.
• Governs QA decisions with reference to Quality Director as final arbiter.
• Lead validation engineering activities and ensure regulatory compliance.

Skills

ISO 13485

QMS

Root Cause Analysis

CAPA

NCEP

Failure Mode Investigation

Data analysis

Minitab

Excel

Nonconformance management

Cross-functional collaboration

Validation

Education

Bachelor's Degree in Engineering

Tools

Minitab

Excel

Job description

• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Read and interpret technical drawings, procedures, and protocols.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• 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.
• 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.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decision.
• 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, technician and inspection staff.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Bachelor's Degree in Engineering, Technology, or related Science.
• Minimum 4 to 5 years of relevant experience in a regulated industry, preferably within the medical device industry.
• Experience in reviewing and approving nonconforming event risk assessments and investigations.
• Strong understanding of quality systems, regulatory requirements, and validation processes.
• Strong analytical mindset with proven problem-solving capability.

Required Skills

• Good understanding of ISO 13485 requirements and QMS regulations.
• Experience running and reviewing nonconforming event risk assessments and investigations.
• Experience executing and supporting the full validation lifecycle, from planning to reporting.
• Strong analytical skills, problem-solving skills, including Root Cause Analysis (RCA).
• Statistical analysis skills using tools such as Excel and Minitab.
• CAPA, NCEP, Failure Mode Investigation, and nonconformance management.
• Validation engineering and process validation expertise.
• Customer complaint investigation and complaint handling experience.
• Technical documentation review and approval.
• Effective communication and cross-functional collaboration skills.

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.