Quality Engineer
Beacon Engineering Resources•Minneapolis, MN
About The Position
The Quality Engineer will be responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance and operational effectiveness. This role involves managing QMS processes such as Audits, CAPA, Document Control, and Training. The engineer will analyze quality data to identify improvement opportunities and support corrective actions. Additionally, they will prepare for and support external audits and inspections, and collaborate cross-functionally on quality planning, risk management, validation, and training initiatives.
Requirements
- Bachelor’s degree in Engineering, Science, Manufacturing, or related field
- 5+ years of experience in Quality Systems, Compliance, or Auditing within a regulated environment
- EU MDR Knowledge
- Strong knowledge of quality systems, regulatory compliance, and risk management
- Experience supporting audits and maintaining compliant processes
- Strong communication, analytical, and problem-solving skills
- Proficiency with Microsoft Office applications
Nice To Haves
- Project management experience
- Lead Auditor or Quality Auditor certification
- Experience with software lifecycle or validation requirements
- Familiarity with international regulatory standards
Responsibilities
- Maintain and improve the Quality Management System (QMS) to ensure compliance and operational effectiveness
- Manage QMS processes including Audits, CAPA, Document Control, and Training
- Analyze quality data, identify improvement opportunities, and support corrective actions
- Prepare for and support external audits and inspections
- Collaborate cross-functionally on quality planning, risk management, validation, and training initiatives
Benefits
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
