Quality Manager

About the role

The Manager, Quality Assurance – Sterilization & Product Release provides strategic leadership and operational oversight for the site's Quality Assurance and Sterilization Release activities. This individual ensures alignment with Boston Scientific’s Quality policies, regulatory requirements, and business goals, while championing a culture of compliance, collaboration, and continuous improvement. As a key member of the site leadership team, this role supports the daily operations of the site and drives initiatives that ensure product quality and regulatory compliance across operations.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Provide leadership and strategic direction for the site s Quality Assurance and Sterilization Release functions, ensuring compliance with Boston Scientific, customer, and regulatory standards.
• Oversee day-to-day operations of the Quality team, including engineers, technicians, and support staff, ensuring effective support of site and corporate goals.
• Support sterilization operations by consulting on quality and sterilization issues, problem-solving, and driving proactive risk mitigation strategies.
• Lead staff management activities including recruitment, workforce planning, skills assessment, workload distribution, performance management, training, and professional development.
• Mentor and coach team members in Lean, Six Sigma, and mistake-proofing methodologies to build operational excellence and technical depth.
• Design, implement, and improve inspection, testing, and validation processes to ensure compliance and process control.
• Conduct statistical analyses and cost-of-quality assessments to drive continuous improvement and address nonconformance trends.
• Lead the development, implementation, and improvement of quality systems, CAPA processes, and process controls across production and lab environments.
• Drive continuous improvement initiatives such as Value Improvement Projects (VIP) and Lean Business Practices (LBP) to increase efficiency and reduce waste.
• Facilitate global product sterility release through ongoing quality assurance activities and direct collaboration with Global Sterility Assurance.
• Serve as a cross-functional quality leader, promoting best practices and partnering with internal stakeholders, suppliers, and vendors to ensure product quality.
• Ensure site compliance with applicable FDA, ISO 13485, ISO 11135, and other relevant global regulations and standards.
• Support the development and evolution of the Quality function’s long-term goals, structure, and performance metrics.
• Perform other related duties as required.

Required qualifications:

• Minimum of 7 years' experience in Quality Assurance, Quality Systems, or Manufacturing in the medical device, pharmaceutical, or other regulated industry
• Minimum of 3 years' experience managing or leading technical or quality teams
• Strong knowledge of FDA regulations, ISO 13485, and ISO 11135
• Demonstrated experience with CAPA systems, validation, risk management, and process controls
• Proven leadership and coaching capabilities across technical and non-technical staff
• Experience collaborating across departments and global teams to achieve business objectives
• Excellent analytical, communication, and problem-solving skills

Preferred qualifications:

• Bachelor s or advanced degree in Engineering, Life Sciences, or a related technical field
• Experience with sterility assurance, sterilization validation, or microbiology-based quality systems
• Lean, Six Sigma, or other continuous improvement certifications
• Experience supporting global manufacturing or sterilization operations
• Familiarity with product release and reverse logistics (returns, clinical, recall, stock management) in a regulated industry

Requisition : 617585

Minimum Salary: $103700

Maximum Salary: $197000

The anticipated compensation listed above and the value of core and optional employee benefits…