Quality System Engineer III

Quality System Engineer III

Work mode:
Hybrid Onsite Location(s):
Maple Grove, MN, US, 55311 Recruiter:
Spencer Gregory Hale

About the role:

The Quality System Engineer III will serve as a Quality representative to provide support of quality initiatives and goals at a departmental, site, and regional level. This role will support Audit Excellence at Maple Grove, specifically focusing on the Internal Audit program to ensure the compliance and effectiveness of the BSC Quality Management System against external regulations/standards and BSC procedures.

At Boston Scientific, we value collaboration and synergy. This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office at least 3 days per week. Your responsibilities include:

• Execute Internal Audits of the Maple Grove Site as assigned
• Audits may include:
  Production, Design, Regulatory, Management Controls, and CAPA
• Evaluate and document the compliance of assigned areas via:
  Tours, Interviews, Documentation and Record Review
• Formulate and document nonconformities and opportunities for improvement
• Understand procedures and evaluate compliance to applicable requirements
• Lead Internal Audits
• Collaborate cross-functionally with Audit Area Management for audit scheduling, execution, and initiation of audit nonconformities
• Develop an Audit Plan, including scope, objectives, criteria, and planned schedule
• Facilitate Audit Opening and Closing Meetings
• Provide work directions to Audit Team
• Complete Audit records, including Audit Report and Audit Trails
• Communicate audit progress and results to Auditees and Leadership
• Support and lead Internal Audit initiatives, continuous improvement opportunities, and/or projects
• Coordinate activities, communicate progress, collaborate on key deliverables, and influence action.
• Make pragmatic, risk-based decisions and provide input regarding how to apply requirements and best practices for processes compliance, efficiency, and effectivity.
• Serve as a Quality System Expert resource as requested
• Support External Audit readiness and execution, including performing production line walks and documentation review.
• Partner cross-functionally to provide guidance on BSC's Quality Management system and external regulations/standards.

Required Qualifications:

• Bachelor's degree
• Minimum of 3 years of relevant quality engineering experience in the medical device or pharmaceutical industry
• Minimum of 1 year experience in a role that includes auditing
• Understanding of regulations/standards applicable to BSC Quality Management (such as 21 CFR 820 and ISO 13485)
• Conceptual, practical, and functional knowledge of quality principles, with a general understanding of related job functions
• Strong verbal and written communication, including technical writing, and organizational skills
• Detail oriented with the ability to analyze information quickly
• Able to use a risk-based approach for making quality and business decisions

Preferred Qualifications:

• 3+ years of experience in audit execution (such as Internal Audits, Supplier Audits, or Regulatory Audits)
• ASQ Certified Quality Auditor
• Proactive, able to work independently with minimal supervision, as a team leader or member
• Ability to collaborate and communicate with all levels of the organization
• Continuous improvement mindset with a passion for Quality
• Proven ability to influence without authority in a matrixed organization
• Strong networking skills to foster collaborative relationships

Requisition  Minimum Salary: $ 78300 Maximum Salary: $ 148800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — 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…