Quality System Engineer III

Quick Facts

Quality System Engineer III (Quality representative)

Hybrid work mode; expected in office at least 3 days per week

Internal Audit program support for the BSC Quality Management System (Maple Grove site and regional alignment)

Description

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

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 compliance 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 (scope, objectives, criteria, planned schedule)
• Facilitate audit opening and closing meetings
• Provide work directions to the 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 on applying requirements and best practices for process compliance, efficiency, and effectiveness
• Serve as a Quality System Expert resource as requested
• Support External Audit readiness and execution, including production line walks and documentation review
• Partner cross-functionally to provide guidance on the BSC Quality Management system and external regulations/standards

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 the BSC Quality Management System (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
• Safety-sensitive role: subject to prohibited substance test

Benefits

Core and optional employee benefits are available; compensation and benefits vary by location and other factors (see benefits information site).