Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health ... Manage the customer complaint process; investigation, documentation and resolution * Coordinate ...
Quality Manager
Cedarburg, WI · On-site
Lead, maintain, execute, and improve the Quality Management System (QMS). * Ensure compliance with ISO 9001:2015 requirements and customer quality standards. * Supervise, coach, mentor, and develop ...
Quality Manager
Cedarburg, WI · On-site
Lead, maintain, execute, and improve the Quality Management System (QMS). * Ensure compliance with ISO 9001:2015 requirements and customer quality standards. * Supervise, coach, mentor, and develop ...
Quality Manager
Cedarburg, WI · On-site
Lead, maintain, execute, and improve the Quality Management System (QMS). * Ensure compliance with ISO 9001:2015 requirements and customer quality standards. * Supervise, coach, mentor, and develop ...
Quality Manager
Cedarburg, WI · On-site
Lead, maintain, execute, and improve the Quality Management System (QMS). * Ensure compliance with ISO 9001:2015 requirements and customer quality standards. * Supervise, coach, mentor, and develop ...
Be Seen First
Maintenance & Systems Manager
Milwaukee, WI · On-site
$95K - $110K/yr
Hold teams accountable for performance, quality, and operational priorities * Manage external ... Oversee maintenance of building systems, utilities, grounds, and infrastructure * Ensure compliance ...
Quick apply
Be Seen First
Maintenance & Systems Manager
Milwaukee, WI · On-site
$95K - $110K/yr
Hold teams accountable for performance, quality, and operational priorities * Manage external ... Oversee maintenance of building systems, utilities, grounds, and infrastructure * Ensure compliance ...
Quality Manager
$90K - $110K/yr
Develop, implement, and maintain quality management systems, procedures, and standards. * Ensure all products meet customer specifications, regulatory requirements, and company quality expectations.
Quick apply
Quality Manager
$90K - $110K/yr
Develop, implement, and maintain quality management systems, procedures, and standards. * Ensure all products meet customer specifications, regulatory requirements, and company quality expectations.
Quality Control Manager
Hartland, WI · On-site
Summary QC Manager will have the opportunity to develop talented employees, maintain world-class quality systems, and ensure customer expectations are consistently exceeded. Incumbent will serve as ...
Quality Control Manager
Hartland, WI · On-site
Summary QC Manager will have the opportunity to develop talented employees, maintain world-class quality systems, and ensure customer expectations are consistently exceeded. Incumbent will serve as ...
As we continue to grow, we are adding a Project Manager (Quality & Continuous Improvement) to lead cross-functional initiatives that strengthen our quality systems, improve processes, and drive ...
As we continue to grow, we are adding a Project Manager (Quality & Continuous Improvement) to lead cross-functional initiatives that strengthen our quality systems, improve processes, and drive ...
Quality & Risk Management * ISO 13485 - Medical Device Quality Management Systems * ISO 14971 - Application of Risk Management to Medical Devices * Software & SiMD * IEC 62304 - Medical Device ...
Quality & Risk Management * ISO 13485 - Medical Device Quality Management Systems * ISO 14971 - Application of Risk Management to Medical Devices * Software & SiMD * IEC 62304 - Medical Device ...
Our steady, strategic growth revolves around a commitment to quality * We are family owned ... managing HR Systems or HRIS teams. * Deep knowledge of Workday HCM, including business processes ...
Our steady, strategic growth revolves around a commitment to quality * We are family owned ... managing HR Systems or HRIS teams. * Deep knowledge of Workday HCM, including business processes ...
Our steady, strategic growth revolves around a commitment to quality * We are family owned ... managing HR Systems or HRIS teams. * Deep knowledge of Workday HCM, including business processes ...
Our steady, strategic growth revolves around a commitment to quality * We are family owned ... managing HR Systems or HRIS teams. * Deep knowledge of Workday HCM, including business processes ...
Quality Manager
$90K - $125K/yr
The Quality Assurance Manager is responsible for the overall quality system of the organization. Responsibilities include managing the day-to-day quality operation activities. Job Duties and ...
Quick apply
Quality Manager
$90K - $125K/yr
The Quality Assurance Manager is responsible for the overall quality system of the organization. Responsibilities include managing the day-to-day quality operation activities. Job Duties and ...
Quality Manager
$100K - $140K/yr
The Quality Assurance Manager is responsible for the overall quality system of the organization. Responsibilities include managing the day-to-day quality operation activities. Job Duties and ...
Quick apply
Quality Manager
$100K - $140K/yr
The Quality Assurance Manager is responsible for the overall quality system of the organization. Responsibilities include managing the day-to-day quality operation activities. Job Duties and ...
Quality Manager
$100K - $130K/yr
The Quality Assurance Manager is responsible for the overall quality system of the organization. Responsibilities include managing the day-to-day quality operation activities. Job Duties and ...
Quick apply
Quality Manager
$100K - $130K/yr
The Quality Assurance Manager is responsible for the overall quality system of the organization. Responsibilities include managing the day-to-day quality operation activities. Job Duties and ...
Manager, Campus ID System
Milwaukee, WI · On-site
$65K - $75K/yr
Manager, Campus ID System Job Category: Academic Staff Employment Type: Regular Job Profile ... across ID systems and connected platforms * Maintainconsistent, high-quality customer service ...
Manager, Campus ID System
Milwaukee, WI · On-site
$65K - $75K/yr
Manager, Campus ID System Job Category: Academic Staff Employment Type: Regular Job Profile ... across ID systems and connected platforms * Maintainconsistent, high-quality customer service ...
Manager, Campus ID System
Milwaukee, WI · On-site
$65K - $75K/yr
Manager, Campus ID System Job Category: Academic Staff Employment Type: Regular Job Profile ... across ID systems and connected platforms * Maintain consistent, high-quality customer service ...
Manager, Campus ID System
Milwaukee, WI · On-site
$65K - $75K/yr
Manager, Campus ID System Job Category: Academic Staff Employment Type: Regular Job Profile ... across ID systems and connected platforms * Maintain consistent, high-quality customer service ...
Plant Quality Control Manager
$90K - $110K/yr
Quality Systems and Continuous Improvement * Maintain compliance with ThermTech#39;s Quality Management System and applicable customer requirements. * Coordinate Management of Change activities ...
Plant Quality Control Manager
$90K - $110K/yr
Quality Systems and Continuous Improvement * Maintain compliance with ThermTech#39;s Quality Management System and applicable customer requirements. * Coordinate Management of Change activities ...
Quality Systems Manager information
See Butler, WI salary details
$53K - $62K
8% of jobs
$62K - $70.9K
12% of jobs
$73.8K is the 25th percentile. Wages below this are outliers.
$70.9K - $79.8K
17% of jobs
The median wage is $87.8K / yr.
$79.8K - $88.7K
15% of jobs
$88.7K - $97.7K
12% of jobs
$97.7K - $106.6K
6% of jobs
$115.1K is the 75th percentile. Wages above this are outliers.
$106.6K - $115.5K
5% of jobs
$115.5K - $124.5K
6% of jobs
$124.5K - $133.4K
13% of jobs
$133.4K - $142.3K
3% of jobs
$142.3K - $151.2K
2% of jobs
$53K
$96.9K
$151.2K
How much do quality systems manager jobs pay per year?
What are the key skills and qualifications needed to thrive as a quality systems manager?
What is the difference between Quality Systems Manager vs Quality Assurance Manager?
| Aspect | Quality Systems Manager | Quality Assurance Manager |
|---|---|---|
| Primary Focus | Developing and maintaining quality management systems and processes | Overseeing product testing and ensuring quality standards are met during production |
| Certifications | ISO 9001 Lead Auditor, CQE | ASQ certifications, QA certifications |
| Work Environment | Quality management departments, compliance teams | Production lines, testing labs |
| Industry Usage | Manufacturing, healthcare, aerospace | Manufacturing, software, healthcare |
While both roles focus on quality, the Quality Systems Manager primarily manages the overall quality management system and compliance, whereas the Quality Assurance Manager concentrates on product testing and ensuring quality during production. Understanding these differences helps in selecting the right career path or hiring the appropriate professional.
What does a quality systems manager do?
As a quality systems manager, your primary responsibilities are monitoring the production processes and ensuring factory machinery/goods are within company and industry requirements. Your duties include weighing, sampling, or testing products for quality and functionality. You may also report the results of quality control tests. You monitor the equipment and people involved, and help with the development and implementation of improved management systems. You are also in charge of creating a standard operating procedure for the specific plant where you work. You check that everything is running at full efficiency and the quality of merchandise is standardized.
How does a quality systems manager typically collaborate with cross-functional teams to drive continuous improvement?

Werfen rating
8.7
Based on 27 frontline employees who took The Breakroom Quiz
Job description
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care
Overview
The Quality Engineer - CAPA and Customer Complaint is responsible for overseeing corrective and preventive actions, managing customer complaints, and ensuring compliance with quality and regulatory standards. This role ensures that US Transplant Technololgy CAPA and complaint processes comply with FDA, ISO 13485, IVDR, and other global regulatory requirements while driving operational excellence.
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)
Responsibilities
Key Accountabilities
CAPA Management:
- Oversee the end-to-end CAPA process, ensuring timely identification, investigation, and closure of corrective and preventive actions
- Supports the review of root cause analyses (e.g., 5 Whys, Fishbone Diagrams, FMEA) to ensure proper and thorough investigations have been conducted and identify systemic issues
- Ensure CAPA effectiveness checks are conducted and documented per regulatory requirements
- Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
- Drive continuous improvement initiatives to optimize efficiency and compliance
Complaint Handling & Investigation:
- Manage the customer complaint process; investigation, documentation and resolution
- Coordinate cross-functional teams (Technical Support, Quality, Regulatory, and Manufacturing) to investigate complaints and implement corrective actions
- Ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events
Regulatory Compliance & Audits:
- Ensure CAPA and complaint processes align with FDA, ISO 13485, EU IVDR, and other global regulations
- Serve as Subject Matter Expert (SME) during regulatory audits and inspections
- Maintain compliant and CAPA metrics for Management Review and continuous improvement initiatives
- Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
- Drive continuous improvement initiatives to optimize efficiency and compliance
- Support other Quality Management Systems as required; applicable subsystems include, but are not limited to, supplier management, risk management and change control
- Other duties as assignedeasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships
- Daily interaction with all departments domestic and international to support CAPA training and CAPA Closure.
- Interaction with Manufacturing Technical Support team in support of product investigations.
- Interaction with Research and Development to support product complaints and product improvements.
- Interaction with Quality Assurance for quality and regulatory compliance.
- Interaction with Customer Technical Support team in support of customer complaint investigation.
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)
Qualifications
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)
Minimum Knowledge & Experience required for the position:
- Bachelor's degree in Engineering, Life Sciences, Quality, and/or related fields; Master's degree preferred
- Minimum 7 years of experience in medical device, pharamaceutical, or biotechnology industries with a focus on CAPA and complaint handling. (Preferably direct experience with IVD's for HLA screening, and ELISA products)
- Strong understanding of FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations
- Expertise in CAPA investigations, root cause analysis (RCA), and risk management (ISO 14971)
- Experience with electronic QMS (eQMS) systems (e.g.,TrackWise, MasterControl, SAP)
- Strong analytical, communication, and leadership skills
- Excellent verbal and written communication skills
- Exhibits a disciplined approach to work ensuring thoroughness, consistency, validation, and accuracy in all tasks and work product
- Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement Skills & Capabilities:
- Effective communication
- Strong leadership
- Proactive problem-solving
- Stategic thinking
- Organizational skills and time management
- Coaching skills for improvement and problem solving
- Continous learning and development mindset
- Conflict resolution
- Foster a positive and inclusive work environmentTravel requirements:
- 5% or less annually
Closing
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com
About Werfen
Sourced by ZipRecruiter
Industry
Health care and social assistance
Company size
1,001 - 5,000 Employees
Headquarters location
L'Hospitalet de Llobregat, Barcelona, ES