Senior Quality Systems Engineer — QMS & Audit Leader

Carl Zeiss Vision Canada Inc.; Minneapolis (MN); On-site; USD 92,000 - 114,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Job summary

ZEISS seeks a Senior Quality Systems Engineer to lead the development, implementation, and continuous improvement of the Quality Management System (QMS) at our Maple Grove, MN facility. You will act as a subject matter expert for quality systems, regulatory compliance, audits, CAPA, and process improvement initiatives.

You’ll own core QMS processes, drive audits, investigate root causes with structured methods, and mentor teams to achieve sustained quality performance.

Qualifications

• 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 collaborate across 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.

Skills

Audits

CAPA investigations

Quality tools

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Quality/Manufacturing

Tools

FMEA

Control Plans

MSA

Root Cause Analysis

Risk Assessment

Job description

ZEISS seeks a Senior Quality Systems Engineer to lead the development, implementation, and continuous improvement of the Quality Management System (QMS) at our Maple Grove, MN facility. You will act as a subject matter expert for quality systems, regulatory compliance, audits, CAPA, and process improvement initiatives.

You’ll own core QMS processes, drive audits, investigate root causes with structured methods, and mentor teams to achieve sustained quality performance.