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.

Senior Quality System Engineer