The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and ...
The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and ...
The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and ...
The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and ...
Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system by supporting customer and ...
Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system by supporting customer and ...
QUALITY SYSTEMS ENGINEER
Hartford, WI · On-site
Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system by supporting customer and ...
QUALITY SYSTEMS ENGINEER
Hartford, WI · On-site
Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system by supporting customer and ...
QUALITY SYSTEMS ENGINEER
Hartford, WI · On-site
Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system by supporting customer and ...
QUALITY SYSTEMS ENGINEER
Hartford, WI · On-site
Under the direction of the Quality Manager, the Quality Systems Engineer is responsible for helping the quality team maintain and improve the quality management system by supporting customer and ...
Supplier Quality Engineer
Ripon, WI · On-site
$87K - $105K/yr
The Supplier Quality Engineer supports the effort of the new design introduction. * Member of the ... Conduct on-site or virtual audits to evaluate supplier quality systems and process capability.
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Supplier Quality Engineer
Ripon, WI · On-site
$87K - $105K/yr
The Supplier Quality Engineer supports the effort of the new design introduction. * Member of the ... Conduct on-site or virtual audits to evaluate supplier quality systems and process capability.
The Quality/Reliability Engineer drives proactive quality initiatives for the Battery Systems portfolio, focusing on building infrastructure for diagnostics and product support to improve warranty ...
The Quality/Reliability Engineer drives proactive quality initiatives for the Battery Systems portfolio, focusing on building infrastructure for diagnostics and product support to improve warranty ...
The Quality/Reliability Engineer drives proactive quality initiatives for the Battery Systems portfolio, focusing on building infrastructure for diagnostics and product support to improve warranty ...
The Quality/Reliability Engineer drives proactive quality initiatives for the Battery Systems portfolio, focusing on building infrastructure for diagnostics and product support to improve warranty ...
The Quality/Reliability Engineer drives proactive quality initiatives for the Battery Systems portfolio, focusing on building infrastructure for diagnostics and product support to improve warranty ...
The Quality/Reliability Engineer drives proactive quality initiatives for the Battery Systems portfolio, focusing on building infrastructure for diagnostics and product support to improve warranty ...
Quality Systems Technician
Stoughton, WI · On-site
Nelson Global engineers, manufactures, and distributes clean and efficient Air & Fluid Transfer ... The Quality Systems Compliance Technician position will assist in completing material compliance ...
Quality Systems Technician
Stoughton, WI · On-site
Nelson Global engineers, manufactures, and distributes clean and efficient Air & Fluid Transfer ... The Quality Systems Compliance Technician position will assist in completing material compliance ...
Quality Systems Specialist
New Richmond, WI · On-site
$26 - $33/hr
Collaboration is at the heart of how we work, engineers, toolmakers, operators, and quality ... systems improvements - Support preparation for internal and external audits, including ...
Quality Systems Specialist
New Richmond, WI · On-site
$26 - $33/hr
Collaboration is at the heart of how we work, engineers, toolmakers, operators, and quality ... systems improvements - Support preparation for internal and external audits, including ...
Quality Systems Technician
Stoughton, WI · On-site
Nelson Global engineers, manufactures, and distributes clean and efficient Air & Fluid Transfer ... The Quality Systems Compliance Technician position will assist in completing material compliance ...
Quality Systems Technician
Stoughton, WI · On-site
Nelson Global engineers, manufactures, and distributes clean and efficient Air & Fluid Transfer ... The Quality Systems Compliance Technician position will assist in completing material compliance ...
Quality Systems Specialist
New Richmond, WI · On-site
$26 - $33/hr
Collaboration is at the heart of how we work, engineers, toolmakers, operators, and quality ... systems improvements - Support preparation for internal and external audits, including ...
Quality Systems Specialist
New Richmond, WI · On-site
$26 - $33/hr
Collaboration is at the heart of how we work, engineers, toolmakers, operators, and quality ... systems improvements - Support preparation for internal and external audits, including ...
Quality Systems Specialist
Madison, WI · On-site
$27.69 - $31.01/hr
Monitor quality system metrics and generate reports to support management review ... Collaborate cross-functionally with manufacturing, engineering, and other departments to drive ...
Quality Systems Specialist
Madison, WI · On-site
$27.69 - $31.01/hr
Monitor quality system metrics and generate reports to support management review ... Collaborate cross-functionally with manufacturing, engineering, and other departments to drive ...
Quality Systems Specialist
Madison, WI · On-site
$27.69 - $31.01/hr
Monitor quality system metrics and generate reports to support management review ... Collaborate cross-functionally with manufacturing, engineering, and other departments to drive ...
Quality Systems Specialist
Madison, WI · On-site
$27.69 - $31.01/hr
Monitor quality system metrics and generate reports to support management review ... Collaborate cross-functionally with manufacturing, engineering, and other departments to drive ...
... Operations, Engineering/Maintenance, and R&D. Role Description Looking to join a growing ... This role will take ownership of the day to day Quality programs and team at a small manufacturing ...
... Operations, Engineering/Maintenance, and R&D. Role Description Looking to join a growing ... This role will take ownership of the day to day Quality programs and team at a small manufacturing ...
Bachelor's degree in a scientific or engineering discipline (advanced degree preferred) * 7+ years of experience with manufacturing quality systems * 3+ years in a leadership or advisory role, with ...
Bachelor's degree in a scientific or engineering discipline (advanced degree preferred) * 7+ years of experience with manufacturing quality systems * 3+ years in a leadership or advisory role, with ...
Systems Manager - Quality
Sheboygan, WI · On-site
Bachelor's degree in a scientific or engineering discipline (advanced degree preferred) * 7+ years of experience with manufacturing quality systems * 3+ years in a leadership or advisory role, with ...
Systems Manager - Quality
Sheboygan, WI · On-site
Bachelor's degree in a scientific or engineering discipline (advanced degree preferred) * 7+ years of experience with manufacturing quality systems * 3+ years in a leadership or advisory role, with ...
Systems Engineer
Monona, WI · On-site
Systems Engineer Location: Madison, WI FTE only Must Have Technical/Functional Skills • Must ... Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the ...
Systems Engineer
Monona, WI · On-site
Systems Engineer Location: Madison, WI FTE only Must Have Technical/Functional Skills • Must ... Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the ...
... QA, Regulatory, Manufacturing, and Marketing Agile product development environment Preferred Background: 3 5 years of Systems Engineering experience Experience with medical devices / diagnostic ...
... QA, Regulatory, Manufacturing, and Marketing Agile product development environment Preferred Background: 3 5 years of Systems Engineering experience Experience with medical devices / diagnostic ...
Quality Systems Engineer information
See Wisconsin salary details
$27.66 - $32.51
5% of jobs
$32.51 - $37.37
14% of jobs
$38.69 is the 25th percentile. Wages below this are outliers.
$37.37 - $42.22
23% of jobs
The median wage is $44.37 / hr.
$42.22 - $47.07
19% of jobs
$47.07 - $51.92
10% of jobs
$53 is the 75th percentile. Wages above this are outliers.
$51.92 - $56.78
19% of jobs
$56.78 - $61.63
7% of jobs
$61.63 - $66.48
1% of jobs
$66.48 - $71.33
0% of jobs
$71.33 - $76.19
0% of jobs
$76.19 - $81.04
2% of jobs
$27
$50
$81
How much do quality systems engineer jobs pay per hour?
What Does a Quality Systems Engineer Do?
A quality systems engineer conducts frequent and detailed quality checks to make sure the products and processes in a manufacturing setting are consistent and meet both industry and client standards as well as legal demands. In this role, you may monitor processes in various industries, so job duties can vary. However, you always play a role in locating and fixing defects. You check tools and materials, conduct tests, and train employees to meet safety requirements. You also closely document any problems for the engineer, who finds a solution. You follow the entire manufacturing process from beginning to end. In this job, you may work in a lab or an office.
What are the key skills and qualifications needed to thrive as a Quality Systems Engineer, and why are they important?
How does a Quality Systems Engineer typically collaborate with cross-functional teams within an organization?
What are Quality Systems Engineers?
What is the difference between Quality Systems Engineer vs Quality Assurance Engineer?
| Aspect | Quality Systems Engineer | Quality Assurance Engineer |
|---|---|---|
| Certifications | ISO 9001, Six Sigma, ASQ certifications | ISO 9001, Six Sigma, ASQ certifications |
| Work Environment | Manufacturing, aerospace, automotive, medical devices | Manufacturing, software, healthcare, consumer products |
| Responsibilities | Developing and maintaining quality management systems, ensuring compliance, process improvement | Testing products, identifying defects, ensuring product quality before release |
While both roles focus on quality, the Quality Systems Engineer primarily develops and maintains quality management systems and processes, ensuring compliance across the organization. The Quality Assurance Engineer concentrates on testing products and identifying defects to ensure product quality before reaching customers. Both roles often collaborate but serve different stages of the quality management lifecycle.

Full-time
Posted 21 days ago
Job description
The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. This role plays a key part in supporting internal and external audits, overseeing document control and CAPA processes, and driving continuous improvement initiatives across the organization. The engineer will collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards. With a strong focus on compliance, process optimization, and risk mitigation, this position is critical in supporting the company’s goal of delivering high-quality products while maintaining a culture of operational excellence and regulatory readiness.
- Act as a role model and ensure safety is built into our QMS and work processes.
- Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.
- Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps.
- Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance.
- Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality.
- Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness.
- Apply problem-solving methodologies to prioritize and resolve quality issues promptly.
- Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality.
- Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance.
- Provide training to employees on quality system requirements to ensure compliance and consistency across departments.
- Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS.
- Assist in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready.
- Drive quality system enhancements, identifying and implementing improvement opportunities across the organization.
- Other duties as required.
- A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field.
- 3-5 years of experience in quality system management within a medical device or other regulated environment.
- Strong knowledge of FSSC 22000, ISO 9001, ISO 13485, 21 CFR Part 820, and industry best practices for QMS.
- Proficient in CAPA processes, risk management strategies, and both internal and external audit processes.
- Demonstrated ability to use QMS software and document control systems to manage regulatory documentation.
- Excellent problem-solving, analytical, and troubleshooting skills.
- Strong verbal and written communication abilities, capable of interacting with all levels of the organization.
- Experience with Six Sigma or other process improvement methodologies to drive quality enhancements.
Ability to work collaboratively in cross-functional teams to ensure successful quality initiatives and improvements.
About Spectrum Plastics Group
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Alpharetta, GA, US
Year founded
1961