- Location
- Penang,MY, MY
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
- Experience
- 9+ years
- Source
- Eightfold
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
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.
Skills
ComplianceProject Management
