Quality Manager

Quality Manager

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

About the Role

At Boston Scientific, we believe quality is fundamental to patient safety and business success. As a Quality Manager supporting the Infection Prevention franchise at our Johns Creek, Georgia site, you will lead quality activities supporting manufacturing, warehouse, and distribution operations.

You will lead and develop a team of quality professionals while ensuring patient safety, product quality, regulatory compliance, and continuous improvement. This role partners cross-functionally to translate Site, Divisional, Regional, and Global Quality strategies into actionable priorities and measurable results.

You will also support the site's digital transformation strategy by building team capabilities and advancing the use of data analytics, automation, artificial intelligence (AI), and digital quality tools to improve decision-making and operational performance.

Your Responsibilities Will Include

• Lead quality activities supporting manufacturing, testing, product release, warehouse, and distribution operations in compliance with Boston Scientific Quality System requirements and applicable FDA, ISO, and other regulatory requirements.
• Lead, coach, and develop quality engineers, technicians, and other team members while establishing priorities, allocating resources, and driving accountability for results.
• Translate Site, Divisional, Regional, and Global Quality strategies into team objectives and measurable deliverables, including supporting achievement of the site's Best 4 Quality objectives.
• Partner with Manufacturing, Operations, Warehouse, Distribution, Engineering, Design Quality, and Supply Chain to resolve complex quality issues, support business priorities, and drive continuous improvement.
• Provide leadership and guidance for quality investigations, nonconformances, CAPAs, risk-based decisions, inspections, statistical process control, audits, and other Quality System activities.
• Review and approve Quality System records, including Nonconforming Material Reports, CAPAs, internal audit records, change notices, and document changes.
• Use quality metrics, data analytics, and business intelligence tools to monitor performance, identify emerging risks and improvement opportunities, and drive sustainable results.
• Champion operational excellence initiatives focused on reducing defects, improving process capability and inspection effectiveness, simplifying processes, and strengthening Quality System performance.
• Support new product development, product transfers, new processes, and sustaining engineering activities by ensuring appropriate Quality resources, deliverables, and representation.
• Support the site's digital transformation strategy through adoption of digital quality solutions, automation, data analytics, and AI-enabled tools that improve quality, efficiency, and decision-making.
• Support organizational readiness for internal audits, regulatory inspections, Management Reviews, and external assessments.
• Serve, when designated, as a delegate for the site Management Representative and support interactions with regulatory authorities and other external stakeholders as required.
• Build strong cross-functional relationships and promote a culture of patient safety, product quality, compliance, accountability, innovation, and continuous improvement.

Required Qualifications

• Bachelor's degree
• Strong functional and technical knowledge of quality engineering principles, Quality Systems, and applicable medical device regulatory requirements.
• Demonstrated people leadership experience, including coaching and developing technical professionals, establishing priorities, allocating resources, and driving accountability.
• Experience leading quality activities within a regulated manufacturing, warehouse, or distribution environment.
• Demonstrated ability to lead complex quality investigations and cross-functional problem-solving efforts using practical, risk-based approaches.
• Experience supporting manufacturing quality activities, including nonconformances, CAPAs, inspections, statistical process control, audits, and product or process specifications.
• Demonstrated ability to use quality metrics and performance indicators to identify risks, establish priorities, and drive operational improvements.
• Demonstrated ability to influence cross-functional stakeholders, manage multiple priorities, and translate business and quality objectives into executable plans.
• Experience leading continuous improvement initiatives resulting in measurable quality, compliance, or operational improvements.

Preferred Qualifications

• Experience leading quality engineers, technicians, or other technical professionals in a regulated medical device environment.
• Experience supporting manufacturing, warehouse, and/or distribution quality operations.
• Experience supporting new product development, product transfers, or sustaining engineering activities.
• Experience with digital quality tools, data analytics, automation, or AI-enabled technologies within Quality or manufacturing functions.
• Experience supporting Management Reviews, site quality objectives, regulatory inspections, or serving as a delegate for a site Management Representative.
• Certification or training in Lean, Six Sigma, Operational Excellence, Data Analytics, Artificial Intelligence, or a related discipline.
• Experience developing technical talent, building team capability, and establishing or improving quality tools, methods, and best practices.