Boston Scientific Senior Quality Systems Engineer 

United States, Minnesota 

901661629

About the role:

As a Senior Quality System Engineer supporting Internal Audit at our Maple Grove site, you will serve as a key Quality representative responsible for driving audit excellence and ensuring alignment with both internal procedures and external regulatory requirements. This role will focus on the execution, leadership, and continuous improvement of our Internal Audit program, contributing to Boston Scientific’s commitment to delivering high-quality, innovative medical solutions. You'll work cross-functionally, influencing teams and supporting our broader Quality System objectives at site, divisional, and global levels.

Your responsibilities will include:

• Execute internal audits of the Maple Grove site in areas such as Production, Design, Regulatory, Management Controls, and CAPA

  • Evaluate and document compliance through tours, interviews, documentation review, and record analysis

  • Identify and document nonconformities and opportunities for improvement

  • Interpret procedures and assess compliance to applicable requirements

• Lead internal audits and manage full audit lifecycle

  • Develop audit plans including scope, objectives, criteria, and schedules

  • Facilitate opening and closing meetings, guide audit teams, and ensure completion of all audit records

  • Communicate audit findings and progress to auditees and leadership

• Serve as a subject matter expert for the Internal Audit program

  • Provide risk-based guidance and practical solutions to support compliant, efficient, and effective processes

  • Support external audits with documentation and context related to internal audit findings

• Drive internal audit initiatives and continuous improvement projects

  • Lead or support cross-functional activities, coordinate deliverables, and influence timely action

• Act as a Quality System resource for external audit readiness

  • Partner with internal teams to provide guidance on Boston Scientific’s Quality Management System and applicable regulations/standards

Required qualifications:

• Bachelor's degree

• Minimum of 5 years' experience in the medical device or pharmaceutical industry

• Minimum of 2 years' experience in a Quality Systems role that includes auditing

• In-depth knowledge of regulations/standards such as 21 CFR 820 and ISO 13485

• Strong understanding of quality principles and interrelated job functions

• Highly detail-oriented with strong analytical skills

• Ability to make sound, risk-based decisions

Preferred qualifications:

• • 5+ years of experience in audit execution (internal, supplier, or regulatory audits)

  • ASQ Certified Quality Auditor

  • Excellent verbal and written communication skills, including technical writing

  • Ability to collaborate and communicate effectively across all levels of the organization

  • Demonstrated ability to work independently or lead in a team setting

  • Continuous improvement mindset and passion for Quality

  • Proven ability to influence without authority in a matrixed environment

  • Strong networking skills to build and maintain effective partnerships

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.