Senior Quality Systems Engineer

Boston Scientific; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific in Maple Grove, MN is seeking a Senior Quality Systems Engineer to provide technical leadership for the Quality Management System (QMS) across CAPA, nonconformances, audits, and management reviews.

The role ensures compliance with FDA QMSR, ISO 13485, ISO 14971, EU MDR and partners with Engineering, R&D, Regulatory and Operations to resolve quality issues and drive improvements in a hybrid work model requiring in-office presence three days per week.

Qualifications

• Bachelor's degree in science or engineering required.
• 5+ years in medical device quality/regulatory environment.
• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR.
• Proven experience in CAPA, audits, and risk management.

Responsibilities

• Lead and support QMS processes including CAPA, nonconforming events, internal and external audits.
• Mentor teams on investigations, root-cause analysis, corrective actions, effectiveness verification.
• Analyze quality metrics and drive data-based improvements.
• Lead continuous improvement initiatives to enhance QMS and compliance.
• Collaborate with Engineering, R&D, Regulatory, Operations to resolve quality issues and implement sustainable solutions.
• Prepare site for regulatory inspections and SME readiness, including finding responses and remediation.

Skills

CAPA

Internal audits

External audits

Management review

Quality metrics

Risk-based decisions

Cross-functional collaboration

Technical writing

Documentation

Project management

Mentoring

Team leadership

Education

Bachelor

Master

Tools

Quality Management Software

Regulatory databases

Job description

Recruiter: Spencer Gregory HaleSenior Quality Systems EngineerAbout the role:The Senior Quality Systems Engineer provides technical leadership and subject matter expertise in the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable regulatory requirements and industry standards.This is a hybrid work mode position located in Maple Grove, MN at the Arbor Lakes Site Location with the expectation to be in the office 3 days per week.Your responsibilities include:Lead and support QMS processes including CAPA, nonconforming events, internal audits, external audits and management review.Ensure compliance with applicable regulatory requirements and standards, including FDA QMSR, ISO 13485, ISO 14971, and EU MDR.Mentor teams leading complex investigations, root-cause analysis, corrective actions, and effectiveness verification.Support internal and external audits and regulatory inspections, including site preparation, SME readiness, finding responses, and remediation activities.Analyze quality metrics and trends to identify systemic risks and drive data-based improvements.Lead continuous improvement initiatives to enhance QMS effectiveness, compliance, and operational efficiency.Partner cross-functionally with Engineering, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues and implement sustainable solutions.Develop and maintain quality procedures, work instructions, and other controlled documentation.Apply risk-based decision-making to quality and compliance issues.Serve as a QMS subject matter expert, providing guidance, training, and mentorship to cross-functional team members across the site.Lead quality-system projects and influence stakeholders to ensure timely, compliant, and effective execution.Partner with Global teams to influence and drive continual improvement within the QMS.What we’re looking for in you:Minimal qualifications:Bachelor's degree and 5+ years or Master's degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environmentUnderstanding of quality system requirements as stated within FDA QMSR, ISO 13485, ISO 14971, and EU MDRTechnical writing and documentation skillsAttention to detail and ability to analyze information quicklyUse a risk-based approach for making quality and business decisionsPreferred Qualifications:Proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible teamAbility to collaborate and communicate with all levels of the organizationContinuous improvement mindset with a passion for QualityDegree(s) in Science or Engineering5+ years of experience in Quality SystemsTraining/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality Management System RegulationHands-on Project Management experienceRequisition ID: 635647Minimum 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 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.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.