Quality Sys Eng - P2

Purpose Statement

Serves as a Quality representative to improve awareness, visibility, communication, and quality initiatives in support of departmental, functional, site, divisional, and corporate quality goals.

Key Responsibilities:

• Drive changes in procedures and standards to improve work efficiency and maintain quality.
• Ensure implementation of internal requirements and external laws, regulations, guidance, and standards applicable to Quality Systems.
• Implement, coordinate, and continuously review CAPA, Internal Audit, and Corporate Compliance programs.
• Facilitate CAPA management across the organization and participate in global CAPA meetings.
• Conduct Internal Audits, identify compliance gaps, and support external audits.
• Conduct Quality System training for employees.
• Lead Quality System improvement initiatives using appropriate problem-solving and continuous improvement methodologies.
• Provide Quality Assurance support for analytical laboratory activities, including Analytical Batch Release, Raw Materials (API), Finished Goods, Stability Testing, and laboratory investigations (OOS, OOT, LIR), ensuring compliance with cGMP and regulatory requirements.

Requirements:

• Degree qualified in Science/Engineering.
• Experience in the medical device industry is desirable.

Required Skills and Knowledge:

• CAPA and Non-Conforming Event management.
• Internal and External Audit experience.
• Analytical Batch Release.
• Pharmacopeia Review and Annual Product Review.ISO 13485, EU MDR, FDA Regulations.

• cGMP and Combination Device Regulations.
• Lead Auditor qualification is desirable.

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.