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

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.