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Capa Jobs in Wisconsin (NOW HIRING)

Nolato AB

WI · On-site

CAPA & Nonconformance Management * Lead investigations into customer complaints, internal nonconformances, and audit findings. * Ensure effective root cause analysis using methodologies such as 5 Why ...

Omya

Food Safety and Quality Manager

Superior, WI · On-site

Monitor quality performance and drive corrective and preventive actions (CAPA). * Lead root cause investigations, deviations, and continuous improvement initiatives. Audits & Regulatory Management

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How much do capa jobs pay per hour?

As of Sep 13, 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 is a CAPA?

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 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 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 August 2026, with employment types broken down into 90% Full Time, 5% Part Time, 4% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $80,092 per year, or $38.5 per hour.

Quality Engineer - Systems Assurance

Waukesha, WI • On-site

UNAVAILABLE
See more jobs at UNAVAILABLEexternal

Other

Posted 26 days ago

Key responsibilities

  • Oversee the end-to-end CAPA process, ensuring timely identification, investigation, and closure of corrective and preventive actions

  • Manage the customer complaint process, including investigation, documentation, and resolution

  • Ensure CAPA and complaint processes comply with FDA, ISO 13485, EU IVDR, and other global regulations

Job description

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 assignedreasonable 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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