Website Boston Scientific
Boston Scientific is hiring for a Quality Systems Engineer position, offering an opportunity to work in a regulated medical-device environment focused on quality systems, compliance, and continuous improvement.
Quality Systems Engineer
The Quality Systems Engineer role is suited to engineering and quality professionals who want to contribute to the development, maintenance, and improvement of quality systems supporting medical-device operations.
Boston Scientific is a global medical-technology company with a broad portfolio of products spanning cardiovascular, respiratory, digestive, neurological, and urological healthcare applications.
Key Responsibilities
The position is expected to involve activities associated with quality-system management and compliance, including:
- Supporting quality-management-system processes and procedures.
- Monitoring and improving quality-system performance.
- Working with cross-functional teams to identify and address quality issues.
- Supporting investigations, corrective and preventive actions, and continuous-improvement initiatives.
- Maintaining compliance with applicable medical-device regulations and internal procedures.
- Reviewing quality data and identifying opportunities for process improvement.
- Supporting audit and inspection readiness.
- Preparing and maintaining quality documentation and records.
- Collaborating with engineering, manufacturing, regulatory, operations, and other functional teams.
- Contributing to risk-based quality and process-improvement activities.
Also Check: Global Clinical Supply Business Support Coordinator – Pfizer, Makati
Skills and Experience
- Engineering or related technical education.
- Experience in quality engineering, quality systems, manufacturing, or a regulated industry.
- Understanding of quality-management-system principles.
- Knowledge of medical-device quality and regulatory requirements is advantageous.
- Strong analytical and problem-solving capabilities.
- Ability to interpret quality data and identify trends.
- Strong written and verbal communication skills.
- Ability to work effectively with cross-functional teams.
- Attention to detail and strong documentation discipline.
- Experience with CAPA, deviations/nonconformances, audits, change control, or related quality processes would be valuable.
To apply for this job please visit bostonscientific.eightfold.ai.
