Quality Manager

Boston Scientific; Alpharetta (GA); On-site; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific seeks a Quality Manager for the Infection Prevention franchise at the Johns Creek, GA site. You will lead quality activities across manufacturing, testing, release, warehouse, and distribution, coaching a team of quality professionals to ensure patient safety, product quality, and regulatory compliance.

You will partner cross-functionally to translate quality strategies into actionable priorities, support digital quality tools adoption, and drive continuous improvement while

Qualifications

• Bachelor’s degree required.
• Experience leading quality activities in regulated manufacturing/warehousing environments.
• Experience with quality investigations, CAPAs, audits, and SPC.

Responsibilities

• Lead quality activities across manufacturing, testing, product release, warehouse, and distribution.
• Coach and develop quality engineers and technicians, set priorities, allocate resources, drive results.
• Collaborate with Manufacturing, Operations, Engineering, Design Quality and Supply Chain to resolve complex quality issues and drive improvements.
• Lead investigations, nonconformances, CAPAs, risk decisions, inspections, audits, and Quality System tasks.
• Use quality metrics and data analytics to monitor performance and identify improvement opportunities.

Skills

Quality engineering principles

People leadership

Cross-functional collaboration

Analytical thinking

Risk-based decision making

Education

Bachelor’s degree

Job description

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 RoleAt 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.Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026 and as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list.Work Model, Sponsorship, and RelocationThis is an on-site position based at Boston Scientific's Johns Creek, Georgia location. Boston Scientific will not offer relocation or sponsorship of an employment visa for this position at this time.Your Responsibilities Will IncludeLead 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 QualificationsBachelor’s degreeStrong 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 QualificationsExperience 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.Requisition ID: 635561Minimum Salary: $ 102100Maximum Salary: $ 194000The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).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 transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.