Senior Quality System Engineer

Key Responsibilities:

• Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)
• Lead and support external inspections and regulatory audits
• Plan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actions
• Identify areas of non-compliance and drive continuous improvement initiatives
• Act as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closure
• Maintain and continuously improve site CAPA processes and systems
• Develop, track, and report CAPA metrics to support management review activities
• Support corrective and preventive action processes across the site
• Collaborate cross-functionally to standardize quality system policies and procedures
• Provide training and guidance to teams on quality system requirements
• Gather and analyze quality system data to support management review and decision making
• Participate in global quality system initiatives and discussions
• Provide quality oversight to analytical laboratory activities, including compliance with cGMP and support for investigations (e.g., OOS/OOT), where applicable

Requirements:

• Bachelor’s Degree in Science, Engineering, or a related field
• Minimum 9 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
• Lead Auditor certification 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.