Boston Scientific Gruppe
Senior Design Quality Assurance Manager - Endoscopy
Boston Scientific Gruppe, Marlborough, Massachusetts, us, 01752
Overview
Senior Design Quality Assurance Manager - Endoscopy. Onsite Location(s): Marlborough, MA, US, 01752. Additional Location(s): N/A. This role is a hybrid position requiring office presence in Marlborough, MA at least three days per week. Relocation assistance is available. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. At Boston Scientific, we value collaboration and strive to advance science for life. This role leads a Capital Equipment Design Quality Assurance team within the Endoscopy division, with responsibilities spanning mechanical/electrical/systems engineering, software quality, and cybersecurity. The Senior DQA Manager ensures product quality and regulatory compliance through Design Control and Risk Management across the product life cycle and partners with Research & Development, Regulatory, Medical Safety, Supplier Engineering, and external vendors. The successful candidate will build networks across global operations, influence diverse stakeholders, and manage a Design Assurance Quality team in Sustaining and New Product Development. Salary information: Minimum Salary $127,900; Maximum Salary $243,000. Compensation is location-dependent and may include additional benefits as outlined by Boston Scientific benefits programs. Responsibilities
Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance. Oversees Design Controls and Risk Management aspects of the Design History File; mitigate risks and ensure regulatory compliance during New Product Development. Translate strategy into action by turning organizational goals into objectives and tactical plans for the Quality Engineering team, focusing on New Product Development projects, complaint reduction, value improvement, and product performance challenges. Owns and drives commercial product monitoring and related sustainment activities, including complaint signal management, CAPA, and regulator responses. Communicate effectively with stakeholders at all levels, presenting complex challenges in clear, actionable terms. Act as a champion for quality disciplines, guiding team direction and execution of product and divisional programs; promote accountability and proactive excellence. Provide guidance and leadership to direct reports on workload, priorities, and project execution; mentor in quality technology, quality principles, regulation, risk management, and design control concepts. Continuously develop direct reports through individual development planning. Determine appropriate staffing levels and schedules, and allocate resources in collaboration with key partners. Ensure activities and deliverables meet regulatory and corporate requirements. Foster a diverse workplace where all participants contribute to organizational objectives. Interface with internal and external audit activities, including direct audit support locally and at international manufacturing sites. Partner with internal and external stakeholders and vendors to achieve quality objectives and provide resolution to quality issues. Required Qualifications
Bachelor’s degree in engineering (Electrical, Computer Engineering, Mechanical, Biomedical, etc.) or equivalent. Minimum of 8 years of related experience in Design Quality or equivalent. Minimum of 3 years of direct or indirect supervisory experience with leadership and team development. Medical device or regulated industry experience. Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with emphasis on design controls, risk management, and design optimization. Ability to travel up to 10% (domestic and international). Preferred Qualifications
Advanced degree in a technical field or business; preferable experience with electro-mechanical products, systems, and/or software engineering. Experience leading technical teams. Strong strategic and critical thinking with the ability to balance long-term vision with executional excellence. Excellent collaboration, communication, and interpersonal skills across cultures and geographies. Ability to drive change in a matrixed, global organization. Experience with problem solving including Six Sigma certifications. Strong verbal and written communication skills in a technical environment. For MA positions:
It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific is committed to solving health challenges through innovation and inclusion. We are an equal opportunity employer, dedicated to creating a diverse and inclusive workplace. Nearest Major Market: Boston
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Senior Design Quality Assurance Manager - Endoscopy. Onsite Location(s): Marlborough, MA, US, 01752. Additional Location(s): N/A. This role is a hybrid position requiring office presence in Marlborough, MA at least three days per week. Relocation assistance is available. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. At Boston Scientific, we value collaboration and strive to advance science for life. This role leads a Capital Equipment Design Quality Assurance team within the Endoscopy division, with responsibilities spanning mechanical/electrical/systems engineering, software quality, and cybersecurity. The Senior DQA Manager ensures product quality and regulatory compliance through Design Control and Risk Management across the product life cycle and partners with Research & Development, Regulatory, Medical Safety, Supplier Engineering, and external vendors. The successful candidate will build networks across global operations, influence diverse stakeholders, and manage a Design Assurance Quality team in Sustaining and New Product Development. Salary information: Minimum Salary $127,900; Maximum Salary $243,000. Compensation is location-dependent and may include additional benefits as outlined by Boston Scientific benefits programs. Responsibilities
Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance. Oversees Design Controls and Risk Management aspects of the Design History File; mitigate risks and ensure regulatory compliance during New Product Development. Translate strategy into action by turning organizational goals into objectives and tactical plans for the Quality Engineering team, focusing on New Product Development projects, complaint reduction, value improvement, and product performance challenges. Owns and drives commercial product monitoring and related sustainment activities, including complaint signal management, CAPA, and regulator responses. Communicate effectively with stakeholders at all levels, presenting complex challenges in clear, actionable terms. Act as a champion for quality disciplines, guiding team direction and execution of product and divisional programs; promote accountability and proactive excellence. Provide guidance and leadership to direct reports on workload, priorities, and project execution; mentor in quality technology, quality principles, regulation, risk management, and design control concepts. Continuously develop direct reports through individual development planning. Determine appropriate staffing levels and schedules, and allocate resources in collaboration with key partners. Ensure activities and deliverables meet regulatory and corporate requirements. Foster a diverse workplace where all participants contribute to organizational objectives. Interface with internal and external audit activities, including direct audit support locally and at international manufacturing sites. Partner with internal and external stakeholders and vendors to achieve quality objectives and provide resolution to quality issues. Required Qualifications
Bachelor’s degree in engineering (Electrical, Computer Engineering, Mechanical, Biomedical, etc.) or equivalent. Minimum of 8 years of related experience in Design Quality or equivalent. Minimum of 3 years of direct or indirect supervisory experience with leadership and team development. Medical device or regulated industry experience. Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with emphasis on design controls, risk management, and design optimization. Ability to travel up to 10% (domestic and international). Preferred Qualifications
Advanced degree in a technical field or business; preferable experience with electro-mechanical products, systems, and/or software engineering. Experience leading technical teams. Strong strategic and critical thinking with the ability to balance long-term vision with executional excellence. Excellent collaboration, communication, and interpersonal skills across cultures and geographies. Ability to drive change in a matrixed, global organization. Experience with problem solving including Six Sigma certifications. Strong verbal and written communication skills in a technical environment. For MA positions:
It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific is committed to solving health challenges through innovation and inclusion. We are an equal opportunity employer, dedicated to creating a diverse and inclusive workplace. Nearest Major Market: Boston
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