Quality System Engineer

Key Responsibilities:

• Support implementation of internal quality system requirements and external regulatory standards (e.g., FDA, ISO 13485, cGMP, EU MDR)
• Drive improvements to procedures and standards to enhance efficiency while maintaining compliance
• Support and coordinate CAPA and compliance programs, including facilitating CAPA activities across functions
• Participate in CAPA management activities and global quality system discussions
• Conduct internal audits to identify gaps, ensure compliance, and drive continuous improvement
• Support audit readiness, including front-room and back-room activities during external audits and inspections
• Deliver quality system training and guidance to employees across the site
• Lead or participate in system and process improvement initiatives using structured problem-solving approaches
• Identify areas of non-compliance and recommend corrective actions to improve overall quality system effectiveness
• Provide quality support and oversight for compliance investigations (e.g., non-conformance, OOS/OOT), where applicable

Requirements:

• Bachelor’s Degree in Science, Engineering, or a related field
• 2–5 years of experience in a manufacturing environment
• Experience in the medical device industry is desirable
• Experience in: Non-conformance and CAPA management; Management Review processes; Internal and external audits

Required Skills & Knowledge:

• Knowledge of ISO 13485, EU MDR, and FDA regulations
• Knowledge of cGMP and combination product/device regulations

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.