Senior Design Quality Assurance Manager - Endoscopy SUD

Senior Design Quality Assurance Manager - Endoscopy SUD

Boston Scientific is currently recruiting for a Senior Design Quality Assurance (DQA) Manager to lead a team in our Marlborough, MA location. This Senior DQA Manager will provide leadership to a team of skilled quality engineers in the Endoscopy division and will be responsible for ensuring product quality and compliance through the application of Design Control and Risk Management principles across product life cycle. This role will be a key partner to the Research & Development, Regulatory, Medical Safety and Manufacturing Engineering teams for Single-Use Endoscopes.

The successful candidate will excel at building strong networks and understanding the interdependencies across global operations. They will influence a diverse set of stakeholders, manage and develop a Design Assurance Quality team in Sustaining and New Product Development.

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

Your responsibilities include :

• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Oversees the Design Controls and Risk Management aspects of Design History File, mitigate risks and ensure compliance with applicable regulatory standards during New Product Development.
• Translate strategy into action by converting broader organizational goals into specific objectives and tactical plans for the Quality Engineering team. Key focuses include New Product Development projects and goals, complaint reduction, value improvement and product performance challenges.
• Owns and drives commercial product monitoring and all related product sustainment activities including complaint signal management, CAPA and management of regulator responses.
• Communicate effectively. Interacts with and influences stakeholders at all levels of the organization, presenting complex challenges in clear and actionable manner.
• Act as a champion for quality disciplines, decisions, and practices. Lead in guiding team direction and execution of product and divisional programs. Promote accountability and a proactive mindset toward excellence.
• Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution. Provides mentorship in quality technology, quality principles and overall regulation, risk management and design control concepts.
• Continuously develops direct reports through individual development planning processes.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Assures activities and deliverables in area of responsibility meet regulatory and corporate requirements.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Directly interfaces with internal and external audit activities including direct audit support locally and at several international manufacturing sites.
• Partners with internal and external stakeholders and vendors to ensure quality objectives are met and to provide solutions to quality issues.

Required Qualifications :

Preferred qualifications :