Senior Quality Systems Engineer Jobs (NOW HIRING)

Additional Location(s): US-MA-Marlborough; US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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:

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

We are seeking a Senior Quality Systems Engineer to serve as a Global Risk Management Process Owner within the Global Quality Systems organization. In this highly collaborative role, you will lead the governance, development and continuous improvement of Boston Scientific's Global Risk Management process to ensure compliance with internal quality standards and global regulatory requirements.

The incumbent will be working across divisions and functions, you will partner with design teams, Global Risk Management sub-process stewards and cross-functional stakeholders to establish standardized processes, strengthen risk management practices and drive enterprise-wide consistency. This role provides an opportunity to influence product quality throughout the product lifecycle while advancing continuous improvement initiatives that support innovation, patient safety and regulatory excellence.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in their assigned local office at least three days per week. This position may be based in our Arbor Lakes, Arden Hills or Maple Grove, Minnesota; Marlborough, Massachusetts; or Spencer, Indiana. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

Serve as the Global Risk Management Process Owner, driving strategic initiatives that strengthen process effectiveness, governance and regulatory compliance.

Develop, maintain and continuously improve global procedures, systems and best practices that support product development and lifecycle risk management.

Partner with Global Risk Management sub-process stewards, design teams and cross-functional stakeholders to ensure consistent implementation of enterprise risk management processes.

Lead Global Communities of Practice to promote collaboration, knowledge sharing, process standardization and adoption of best practices across divisions.

Evaluate trends identified through quality system audits, regulatory submissions, management reviews and quality metrics to identify opportunities for process improvements and corrective actions.

Partner with upstream and downstream process owners to maintain effective integration between Global Risk Management and related quality system processes, including Design Controls, Production and Process Controls, Material Controls and Post Market Surveillance.

Support internal audits, external audits and regulatory inspections by providing documentation, process expertise and audit responses.

Monitor compliance with Global Quality System procedures, corporate policies and applicable regulatory requirements.

Lead Global Corrective and Preventive Action (CAPA) activities, including complex, cross-functional and multi-site investigations that drive sustainable process improvements.

Apply structured problem-solving methodologies to identify, prioritize and resolve quality system issues while driving continuous improvement and operational excellence.

Support the development and implementation of streamlined business processes that advance VIP and enterprise continuous improvement objectives.

Required qualifications:

Minimum Bachelor's degree in Engineering, Science, Health Sciences or another related discipline.

Minimum of 5 years' experience in medical device Design Controls and Risk Management.

Strong knowledge of Design Controls, Risk Management principles and product lifecycle quality processes.

Working knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and other applicable global medical device regulations.

Demonstrated experience leading cross-functional initiatives and influencing stakeholders across a global matrix organization.

Strong analytical, problem-solving and decision-making skills.

Excellent written, verbal and presentation skills.

Preferred qualifications:

Proven experience supporting health care professional (HCP) training programs.

Demonstrated experience supporting internal audits, external audits or regulatory inspections.

Advanced project management skills with demonstrated success managing multiple initiatives and competing priorities.

Demonstrated facilitation and stakeholder engagement skills with experience leading cross-functional teams and Communities of Practice.

Advanced proficiency with Microsoft 365 applications, including Teams, Excel, PowerPoint and Word.

Experience driving continuous improvement initiatives using Lean, Six Sigma or other process improvement methodologies.

Requisition ID: 631118 

Minimum Salary: $ 89200 

Maximum Salary: $ 169500 

The 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 atwww.bostonscientific.comand follow us onLinkedIn.

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.