Quality Manager

About The Role

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.

At Boston Scientific this role follows an onsite work model requiring employees to be in our local office five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• 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.

• Bachelor's or Master's degree or equivalent combination of education and experience.
• Minimum of 15 years experience in the medical device industry.
• Minimum of 5 years experience in quality management.
• Experience working in Quality within catheter design and production or a similar medical device environment.
• Demonstrated experience with Design Controls, Risk Analysis, Process and Product Validation and statistical methods.
• Applied understanding of 21 CFR 820, EN ISO 13485:2016 and ISO 14971:2019.
• Expertise in product sterilization, biocompatibility and clean room compliance.
• Proven ability to lead through influence, manage sensitive situations and interact effectively with executive stakeholders.

• Strong verbal and written communication skills with an ability to generate clear, concise and timely reports.
• Ability to manage significant workloads, prioritize effectively and deliver results under pressure.
• High attention to detail, accuracy and proactive problem‑solving skills.
• Strong interpersonal and listening skills, with the ability to adapt to change and build positive working relationships.
• Demonstrated success in creating realistic plans, setting goals and executing cross‑functional initiatives efficiently.

Requisition

Minimum Salary: $103,700

Maximum Salary: $197,000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see  – will vary…