Senior Quality Systems Engineer

ZEISS Group•Minneapolis, MN

1d•$92,000 - $114,000•Onsite

About The Position

The Senior Quality Systems Engineer is responsible for leading the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS). This role serves as a subject matter expert for quality systems, regulatory compliance, internal and external audits, CAPA, and process improvement initiatives.

Requirements

Bachelor's degree in Engineering, Quality, Manufacturing, or related technical field.
5+ years of experience in Quality Engineering, Quality Systems, Manufacturing Quality, or related discipline.
Working knowledge of ISO 9001, 17025, and 14001
Demonstrated experience leading audits, CAPA investigations, and quality system improvements.
Proficiency in quality tools and methodologies, including FMEA, Control Plans, MSA, Root Cause Analysis, and Risk Assessment.
Excellent communication, presentation, and interpersonal skills, with the ability to effectively collaborate and build relationships across all organizational levels.

Responsibilities

Lead the maintenance and continuous improvement of the Quality Management System to ensure compliance with applicable standards, regulations, and customer requirements.
Own and improve core quality system processes, including CAPA, document control, change management, internal audits, management reviews, nonconformance management, and training systems.
Lead internal, external, customer, and certification audits and ensure timely closure of findings.
Facilitate complex root cause investigations using structured problem-solving methodologies such as 8D, A3, Fishbone, 5 Why, and FMEA.
Drive corrective and preventive actions to eliminate recurring issues and improve system effectiveness.
Analyze quality and operational performance data to identify trends, risks, and improvement opportunities.
Lead Management Review preparation, KPI reporting, and quality system performance monitoring.
Perform other duties and special projects as assigned.
Provide guidance and mentoring to other functional teams on QMS requirements and best practices.