Quality Manager

Quality Manager

The Manager, Quality will lead the Quality Engineering and Incoming Quality Control (QC) team responsible for medical product design and manufacturing at Bolt Medical. This leadership role ensures compliance with Boston Scientific's Quality Management System (QMS) and all applicable regulatory requirements, including but not limited to 21 CFR 820, EN ISO 13485 : 2016, EN ISO 14971 : 2019, and related standards.

This position requires a proactive and strategic quality leader who will drive system excellence, continuous improvement, and team development while supporting the company's mission to deliver safe and effective medical devices.

Your responsibilities will include :

• Lead the development and implementation of quality policies and procedures that ensure compliance with applicable U.S. and international regulatory standards.
• Manage Quality Control functions related to disposable product operations, including receiving inspection, in-process inspection, final inspection, product release, NCR management, clean room monitoring, and supplier quality.
• Oversee metrology and calibration activities.
• Champion initiatives related to quality reporting systems and continuous improvement efforts.
• Identify opportunities for risk reduction and cost improvement while maintaining quality excellence.
• Provide leadership, coaching, mentoring, and development for Quality team members and cross-functional stakeholders.
• Serve as a site advocate for Quality Best Practices and current Good Manufacturing Practices (cGMP).
• Collaborate with engineering teams to develop and maintain Risk Management documentation, including FMEAs and hazard analyses.
• Build and scale the Quality Engineering function for disposable devices in alignment with BSCs growth strategy.
• Contribute to audits and regulatory inspections, providing expert guidance on quality systems.
• Set operational objectives, delegate assignments, and ensure timely completion of work by team members.
• Directly manage departmental activities, including performance, staffing, and budget.
• Ensure full compliance with quality system procedures and regulatory requirements.
• Foster a culture of collaboration, accountability, positivity, and continuous improvement.
• Demonstrate professionalism in all interactions with internal stakeholders and external partners.

Required qualifications :

Preferred qualifications :