Quality Engineer III

About the role

Boston Scientific is seeking a Quality Engineer III to lead site‑level NCEP coordination, ensuring compliance with quality policies, regulations, and continuous improvement initiatives. The role blends on‑site and remote work in a hybrid model, supporting product and process quality across the organization.

Key responsibilities

• Check and support execution and investigation of NCEPs.
• Track and monitor progress of open NCEPs, ensuring deadlines and documentation compliance.
• Mentor NCEP owners and teams throughout the NCEP process.
• Review and approve NCEP records, confirming corrective actions are appropriate, sustainable, and compliant.
• Provide day‑to‑day support for eCAPA activities, including training, system access, and issue resolution.
• Participate in NCEP Community of Practices to share best practices.
• Identify and resolve complex exceptions to work assignments.
• Drive continuous improvements in product and process quality.
• Apply knowledge of QSR and ISO/MDD standards to daily decisions.
• Use problem‑solving principles to review investigations and enhance quality.
• Offer technical guidance to Associate Quality Engineers.
• Support internal and external audits and assist during audit activities.
• Contribute to projects as required.

Required profile

• Commitment to the Quality Policy and patient safety.
• Understanding of regulations governing quality systems.
• Familiarity with QSR and ISO/MDD standards.
• Experience with problem‑solving methodologies.
• Ability to provide technical guidance and mentorship.
• Knowledge of internal auditing processes.
• Strong collaboration skills and motivation to achieve department objectives.

Required skills

• QSR (Quality System Regulation) knowledge.
• ISO/MDD standards expertise.
• eCAPA system usage.
• NCEP coordination and documentation.
• Problem‑solving principles.
• Internal audit support.