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Capa Jobs in Wisconsin (NOW HIRING)

Actalent

Quality Manager

Germantown, WI · On-site

Manage non-conformance issues by identifying root causes, implementing corrective and preventive actions (CAPA), and monitoring the effectiveness of those actions. * Audit all quality systems to ...

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

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$13

$38

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How much do capa jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for capa in Wisconsin is $38.51, according to ZipRecruiter salary data. Most workers in this role earn between $29.19 and $44.78 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of a CAPA specialist?

A CAPA specialist is responsible for investigating quality issues, identifying root causes, and implementing corrective and preventive actions to ensure ongoing compliance and product integrity. Their typical day involves reviewing nonconformance reports, collaborating with cross-functional teams, documenting findings, and tracking the progress of CAPA initiatives using specialized software. CAPA specialists also prepare reports for audits and may facilitate meetings to drive continuous improvement activities. This role often requires balancing multiple projects and deadlines in a regulated environment, making organizational and communication skills crucial for success.

What are the key skills and qualifications needed to thrive in the Capa position, and why are they important?

To thrive as a CAPA (Corrective and Preventive Action) specialist, you need expertise in quality management systems, root cause analysis, and compliance with industry standards, typically backed by a degree in engineering, life sciences, or a related field. Familiarity with CAPA software, regulatory frameworks (such as ISO 13485 or FDA 21 CFR Part 820), and document control systems is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital soft skills for this role. These skills ensure effective problem-solving and sustained compliance, which are essential for maintaining product quality and meeting regulatory requirements.

What is a CAPA job?

A CAPA (Corrective and Preventive Action) job involves identifying, investigating, and resolving quality issues in industries like manufacturing, healthcare, and pharmaceuticals. CAPA professionals analyze root causes of defects or process failures and implement corrective actions to prevent recurrence. They ensure compliance with regulatory standards, document findings, and improve overall quality management systems. Their role is critical in maintaining product safety, efficiency, and regulatory adherence.

What are the most commonly searched types of Capa jobs in Wisconsin? The most popular types of Capa jobs in Wisconsin are:
What are popular job titles related to Capa jobs in Wisconsin? For Capa jobs in Wisconsin, the most frequently searched job titles are:
What job categories do people searching Capa jobs in Wisconsin look for? The top searched job categories for Capa jobs in Wisconsin are:
Capa jobs near you
Infographic showing various Capa job openings in Wisconsin as of July 2026, with employment types broken down into 87% Full Time, 7% Part Time, 1% Temporary, 4% Contract, and 1% Nights. Highlights an 94% Physical, 3% Hybrid, and 3% Remote job distribution, with an average salary of $80,092 per year, or $38.5 per hour.
Quality Engineer - Systems Assurance

Quality Engineer - Systems Assurance

Werfen

Waukesha, WI • On-site

Full-time

Posted 3 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

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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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