Quality System Engineer III

Boston Scientific•Maple Grove, MN

3d•$78,300 - $148,800•Hybrid

About The Position

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. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.