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.
