Quality Systems Lead: QMS, CAPA & Audits

ZEISS Group; Osseo (MN); On-site; USD 92,000 - 114,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Vacation and sick pay

Job summary

ZEISS Group in Maple Grove, MN is seeking a Senior Quality Systems Engineer to lead the development, implementation, and continuous improvement of the Quality Management System (QMS). You will serve as a SME for quality systems, regulatory compliance, audits, CAPA, and process improvement initiatives.

You will drive root cause investigations, manage CAPA and audit programs, and mentor cross-functional teams to ensure QMS effectiveness.

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.

Responsibilities

• Lead the maintenance and continuous improvement of the Quality Management System to ensure compliance with standards and customer requirements.
• Own and improve core quality system processes, including CAPA, document control, change management, internal audits, and management reviews.
• Lead internal, external, customer, and certification audits and ensure timely closure of findings.
• Facilitate root cause investigations using structured problem-solving methodologies (8D, A3, Fishbone, 5 Why, FMEA).
• Drive corrective and preventive actions to eliminate recurring issues and improve system effectiveness.

Skills

Quality Systems

CAPA

Audits

Quality Tools

Communication

Education

Bachelor's degree in Engineering

Tools

FMEA

Control Plans

MSA

Root Cause Analysis

Risk Assessment

Job description

ZEISS Group in Maple Grove, MN is seeking a Senior Quality Systems Engineer to lead the development, implementation, and continuous improvement of the Quality Management System (QMS). You will serve as a SME for quality systems, regulatory compliance, audits, CAPA, and process improvement initiatives.

You will drive root cause investigations, manage CAPA and audit programs, and mentor cross-functional teams to ensure QMS effectiveness.