Senior Quality Systems Engineer

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

About Us:

How many companies can say they’ve been in business for over 180 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region:

This position is located in our Maple Grove, MN facility. Onsite Monday-Friday.

What’s the role?

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.

Sound Interesting?

Here’s what you’ll do:

• 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.

Do you qualify?

• 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.

The annual pay range for this position is $92,000 – $114,000. This position is also eligible for a performance bonus.

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay
• The list goes on!

Keywords: 8D, A3, Fishbone, 5 Why, FMEA CAPA.

Your ZEISS Recruiting Team:
Holly Greenwood-Mosher

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).