Senior Quality Engineer

Boston Scientific; Penang; On-site; MYR 80,000 - 110,000; Full time

Job summary

Boston Scientific in Penang is seeking an experienced Quality Engineer to lead quality initiatives, ensuring compliance with specifications and driving continuous improvement. Candidates should have a Bachelor's degree in Science or Engineering and a minimum of 9 years of experience in a manufacturing environment, preferably in the medical device industry.

The role involves problem-solving, technical mentorship, and collaboration with cross-functional teams to address quality issues. Strong leadership and communication skills are essential.

Qualifications

• Minimum 9 years of experience in a manufacturing environment with strong exposure to operations quality.
• Experience in the medical device industry is preferred.
• Experience managing direct reports or in a people management role is an added advantage.

Responsibilities

• Lead structured problem-solving and provide sound engineering and quality recommendations.
• Interpret technical drawings, procedures, and specifications to ensure compliance.
• Make quality-related decisions, including disposition of non-conforming products.
• Investigate manufacturing defects and implement effective CAPA.
• Drive continuous improvement initiatives across the product lifecycle.

Skills

Interpersonal skills

Problem-solving skills

Communication skills

Process validation

Leadership capability

Education

Bachelor's Degree in Science, Engineering, or related field

Job description

Key Responsibilities

• Lead structured problem‑solving and provide sound engineering and quality recommendations
• Interpret technical drawings, procedures, and specifications to ensure compliance
• Make quality‑related decisions, including disposition of non‑conforming products
• Investigate manufacturing defects, non‑conformances, and customer complaints; identify root causes and implement effective CAPA
• Support and lead quality investigations, including complaint handling and failure analysis
• Review and approve validation, operational, and test data to ensure compliance with specifications
• Drive continuous improvement initiatives across the product lifecycle
• Provide guidance and technical mentorship to junior team members
• Collaborate with cross‑functional teams, suppliers, and stakeholders to resolve quality issues
• Support internal audits and ensure compliance with regulatory and quality system requirements

Requirements

• Bachelor’s Degree in Science, Engineering, or related field
• Minimum 9 years of experience in a manufacturing environment, with strong exposure to operations quality
• Experience in the medical device industry is preferred
• Experience managing direct reports or in a people management role is an added advantage

Required Skills & Competencies

• Good interpersonal, problem‑solving, and communication skills
• Experience in process validation and strong leadership capability
• Proven ability to resolve issues using structured problem‑solving tools, supported by strong knowledge in quality operations, including product risk assessment and data analysis, to identify root causes and implement corrective actions
• Good understanding of ISO 13485 and QMSR (or equivalent regulatory requirements)
• Experience leading non‑conforming event risk assessments and investigations
• Exposure to project management or involvement in cross‑functional projects is an added advantage