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Quality Assurance Systems Administrator Jobs (NOW HIRING)

Michael Foods Inc.

QA Systems Coordinator

Britt, IA · On-site

This is achieved through the implementation and monitoring of the Quality Systems programs and the mentoring of these programs to all departments in the facility. This position has the responsibility ...

Michael Foods Inc.

QA Systems Coordinator

Britt, IA · On-site

This is achieved through the implementation and monitoring of the Quality Systems programs and the mentoring of these programs to all departments in the facility. This position has the responsibility ...

Victaulic

Quality Systems Engineer

Easton, PA · On-site

Support and enhance global quality assurance systems, including document control, nonconformance management, CAPA, audit management, and training systems. * Act as a key user or system administrator ...

Victaulic

WI · On-site

Act as a key user or system administrator for QMS platforms, ensuring proper configuration, data ... Strong understanding of quality assurance principles, documentation control, and compliance ...

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Quality Assurance Systems Administrator information

What does a quality assurance systems administrator do?

A Quality Assurance Systems Administrator is responsible for managing and maintaining the systems and software that support quality assurance processes within an organization. Their duties often include configuring QA tools, ensuring data integrity, managing user access, and supporting compliance with industry standards. They also troubleshoot system issues, coordinate with IT and QA teams, and help implement updates or improvements to QA systems. This role is crucial for ensuring that quality processes run smoothly and efficiently.

What are the key skills and qualifications needed to thrive as a quality assurance systems administrator?

To thrive as a Quality Assurance Systems Administrator, you need a solid background in quality management principles, knowledge of regulatory standards, and expertise in system administration, often backed by a relevant degree or certification. Familiarity with quality management software (such as ISO 9001-compliant systems), document control tools, and database management systems is typically required. Problem-solving abilities, attention to detail, and strong interpersonal skills help ensure effective collaboration and continuous improvement. These competencies are crucial for maintaining compliance, streamlining quality processes, and supporting organizational excellence.

How does a quality assurance systems administrator typically collaborate with other departments to support compliance and process improvements?

A Quality Assurance Systems Administrator works closely with teams such as manufacturing, regulatory affairs, IT, and quality control to ensure that all quality management systems are properly maintained and compliant with industry standards. They facilitate communication between departments regarding system updates, audits, and corrective actions, and often lead training sessions to help staff understand new procedures. This collaborative approach helps identify improvement opportunities, ensures consistent documentation practices, and supports a culture of continuous quality improvement across the organization.

What is the difference between Quality Assurance Systems Administrator vs Quality Assurance Analyst?

AspectQuality Assurance Systems AdministratorQuality Assurance Analyst
CertificationsISO, ISTQB, or similarISTQB, Six Sigma, or similar
Work EnvironmentIT and software systems managementTesting and evaluating products or software
Employer UsageIT departments, software companiesManufacturing, software, or service industries
Common Search IntentSystem administration, configuration, and maintenanceProduct quality testing and analysis

While both roles focus on quality assurance, the Quality Assurance Systems Administrator primarily manages and maintains QA systems and infrastructure, ensuring smooth operation. In contrast, the Quality Assurance Analyst concentrates on testing products or software to identify defects and improve quality. Understanding these differences helps employers and job seekers target the right skills and responsibilities for each role.

What cities are hiring for Quality Assurance Systems Administrator jobs?

Cities with the most Quality Assurance Systems Administrator job openings:

What states have the most Quality Assurance Systems Administrator jobs?

States with the most job openings for Quality Assurance Systems Administrator jobs include:

What are popular job titles related to Quality Assurance Systems Administrator jobs?

For Quality Assurance Systems Administrator jobs, the most frequently searched job titles are:

Infographic showing various Quality Assurance Systems Administrator job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution.

Quality Engineer - Systems Assurance

Waukesha, WI • On-site

Werfen
Health Care and Social Assistance • 1 - 5K employees
Learn more about Werfenexternal

Full-time

Re-posted 12 days ago

Werfen rating

8.7

Company rating: 8.7 out of 10

Based on 27 frontline employees who took The Breakroom Quiz

Job description

Introduction
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

What Werfen employees say

Pay

Benefits

Hours and flexibility

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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

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