Sr. Engineer, Quality (Medical Devices)

Location: Pasir Gudang, Malaysia; onsite work in office, laboratory, and manufacturing environments

Company

Bowers & Wilkins develops and manufactures products that require structured quality assurance, product safety certification, and regulatory compliance.

What you will do

• Support the Quality Manager and apply quality engineering tools throughout product development, manufacturing, inspection, and testing.
• Ensure compliance with internal procedures, FDA 21 CFR Part 820, ISO 13485, CMDR, MDD 93/42/EEC, and other applicable international standards.
• Lead and participate in root-cause investigations, failure analysis, CAPA, NCR resolution, supplier issue resolution, and continuous improvement activities.
• Review and verify Device History Records and related documentation, identify discrepancies, and coordinate timely corrective actions.
• Support management reviews, internal and external audits, customer feedback activities, product release, and regulatory compliance initiatives.
• Participate in risk analysis and work with UL, CSA, and external laboratories to obtain product safety certifications.

Requirements

• 1–3 years of experience in manufacturing, quality assurance, or document control.
• Experience with root-cause investigation, failure analysis, corrective and preventive actions, quality system audits, and project management.
• Working knowledge of Device History Records, Device Master Records, quality system documentation, and document management systems.
• Understanding of GMP and FDA 21 CFR Part 820 is highly preferred; knowledge of ISO 13485 and related medical-device standards is relevant.
• Strong attention to detail, communication, documentation, problem-solving, leadership, independence, flexibility, and adaptability.
• Associate’s or Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field; ability to travel internationally and locally with a valid passport and driver’s license.

Nice to have

• Experience with Microsoft Office, ERP or QMS software, and statistical tools such as Minitab or SQC Pack.
• Technical experience in electronic manufacturing and evaluating products against quality standards.

Culture & Benefits

• Work spans office, laboratory, manufacturing, audit, and testing environments.
• Regular sitting, standing, walking, and occasional extended standing are required.
• Ability to recognize and differentiate colors and lift up to 50 pounds is required.
• Some international and local travel is required.