Senior Quality Systems Lead: QMS, Audits & CAPA

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 development, implementation, and continuous improvement of the Quality Management System. You will own core quality processes like CAPA, document control, change management, audits, nonconformance, and training.

Qualifications include a bachelor's degree in engineering or related field, 5+ years in quality systems, ISO 9001/17025/14001, and strong problem-solving skills with tools like FMEA and RCA.

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 with quality tools and methodologies (FMEA, Control Plans, MSA, RCA, Risk Assessment).

Responsibilities

• Lead the maintenance and continuous improvement of the Quality Management System for compliance.
• Own core quality processes: CAPA, document control, change management, internal audits, management reviews, nonconformance, training.
• Lead internal, external, customer, and certification audits; ensure timely closure of findings.
• Drive root cause investigations using 8D, A3, Fishbone, 5 Why, and FMEA; implement corrective actions.
• Analyze data to identify trends and opportunities; prepare KPI reports.

Skills

Auditing experience

Data analysis

Cross-functional collaboration

Problem solving

Quality mindset

Education

Bachelor's degree in Engineering/Quality/Manufacturing

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. You will own core quality processes like CAPA, document control, change management, audits, nonconformance, and training.

Qualifications include a bachelor's degree in engineering or related field, 5+ years in quality systems, ISO 9001/17025/14001, and strong problem-solving skills with tools like FMEA and RCA.