Senior Quality Engineer - Global Post Market Support

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Senior Quality Engineer to support global post-market complaint handling and regulatory compliance. You will establish robust process controls, apply SPC, and drive continuous improvement from intake to reporting.

Lead root cause investigations, develop CAPAs, and collaborate with Quality, Regulatory and IT teams to maintain SOPs and control plans in a hybrid work environment.

Qualifications

• Bachelor’s degree in industrial engineering, statistics or a related technical field.
• 5+ years of quality control experience in a regulated industry.
• Experience with SPC and quality data analysis.
• Knowledge of medical device regulations (ISO 13485, EU MDR) is favorable.

Responsibilities

• Establish robust process controls for complaint handling outputs.
• Lead CAPA investigations and implement preventive actions.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Document SOPs and control plans for consistency.

Skills

QC experience

SPC

Cross-functional collaboration

Statistical analysis

Root cause analysis

Education

Bachelor's degree in industrial engineering, statistics or a related technical field

Job description

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple GroveDiversity - 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 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. This recognition is complemented by our broader workplace culture: 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 Engineer to support our global post-market complaint handling processes. In this role you will establish, maintain and continuously improve process controls that help ensure the reliability of post-market complaint handling outputs. You will provide quality oversight to support compliance with FDA and other global regulatory requirements while advancing process effectiveness, stability and continuous improvement.Work model, sponsorship:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:Establish robust process controls for complaint handling outputs to ensure alignment with customer requirements and maintain reliable process performance.Apply expertise in quality control, statistical methods and systems thinking to drive continuous improvement of the complaint handling process.Evaluate the end-to-end complaint handling process, from intake through adverse event reporting, to identify systemwide dependencies, bottlenecks and potential failure modes and proactively mitigate risk.Lead and participate in root cause investigations for recurring process failures and implement effective corrective and preventive actions (CAPAs).Collaborate with the Complaint Handling, Post-Market Surveillance, Risk Management, and IT and Systems teams to support process effectiveness and compliance.Provide technical leadership to a team of global and divisional subject matter experts responsible for monitoring the complaint handling process.Coordinate with global and divisional teams to create and maintain clear documentation, including standard operating procedures (SOPs), work instructions and control plans, to support consistency and compliance with medical device regulatory requirements.Collect, analyze and report key complaint handling process outputs and trends to senior management.Translate customer needs into process requirements for critical outputs, such as complaint codes, ensuring downstream users have reliable information for analysis and decision-making.Qualifications:Required qualifications:Bachelor's degree in industrial engineering, statistics, sciences or a related technical discipline.Minimum of 5 years' experience in a quality control-related role within a regulated industry, preferably medical devices or pharmaceuticals.Experience with statistical process control (SPC) and other statistical tools for quality data analysis, with an emphasis on applying SPC to business processes.Experience managing cross-functional projects in a regulated environment.Preferred qualifications:ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification.Familiarity with systems thinking principles and the ability to apply them to complex business processes.Working knowledge of relevant medical device regulations and standards, including the European Union Medical Device Regulation (EU MDR), ISO 13485 and ISO 14971.Exceptional attention to detail and a methodical approach to data analysis.Excellent problem-solving, influencing and critical-thinking skills.Excellent written and verbal communication skills, including the ability to present complex data to diverse audiences.Demonstrated ability to collaborate effectively with cross-functional teams.Proactive and accountable mindset with a focus on delivering solutions.Requisition ID: 633704Minimum Salary: $ 85000Maximum Salary: $ 161500The 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.