Quality Manager

Quality Manager

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.

Your responsibilities will include :

• 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 :

Preferred qualifications :