Senior Quality Systems Lead — QMS, CAPA and Audits

ZEISS Group; 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 Group in Maple Grove, MN is seeking a Senior Quality Systems Engineer to lead the Quality Management System, audits, CAPA investigations, and continuous improvement initiatives. The role drives core QMS processes, supports regulatory compliance, and mentors cross-functional teams in quality practices.

You will analyze quality data, manage nonconformances, and coordinate management reviews to ensure product quality and process excellence in a high-tech manufacturing environment.

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 all levels of the organization.

Responsibilities

• Lead maintenance and continuous improvement of the Quality Management System to ensure compliance with standards, regulations, and customer requirements.
• Own and improve core quality system processes, including CAPA, document control, change management, internal audits, management reviews, nonconformance, and training systems.
• Lead internal, external, customer, and certification audits and ensure timely closure of findings.
• Facilitate root cause investigations using methods like 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 on QMS requirements to other functional teams.

Skills

Quality engineering

Audits leadership

CAPA

FMEA

Root cause analysis

MSA

Risk assessment

Document control

Change management

Quality data analysis

Education

Bachelor's degree in Engineering

Job description

ZEISS Group in Maple Grove, MN is seeking a Senior Quality Systems Engineer to lead the Quality Management System, audits, CAPA investigations, and continuous improvement initiatives. The role drives core QMS processes, supports regulatory compliance, and mentors cross-functional teams in quality practices.

You will analyze quality data, manage nonconformances, and coordinate management reviews to ensure product quality and process excellence in a high-tech manufacturing environment.