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Capa Manager Jobs in Indiana (NOW HIRING)

Autocar, LLC

Quality Manager (QA/QC)

Hagerstown, IN · On-site

Drive root cause analysis (RCA) and implement corrective and preventive actions (CAPA) * Establish ... Manage, coach, and develop a team of quality engineers and inspectors * Oversee calibration systems ...

Autocar, LLC

Quality Manager (QA/QC)

Hagerstown, IN · On-site

Drive root cause analysis (RCA) and implement corrective and preventive actions (CAPA) * Establish ... Manage, coach, and develop a team of quality engineers and inspectors * Oversee calibration systems ...

Autocar, LLC

Quality Manager (QA/QC)

Hagerstown, IN · On-site

Drive root cause analysis (RCA) and implement corrective and preventive actions (CAPA) * Establish ... Manage, coach, and develop a team of quality engineers and inspectors * Oversee calibration systems ...

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience interacting with manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering functions. * Proficiency with Microsoft Office ...

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

Responsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.). * Identify and implement activities geared to standardize and ...

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience interacting with manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering functions. * Proficiency with Microsoft Office ...

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience interacting with manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering functions. * Proficiency with Microsoft Office ...

Scorpion Therapeutics

Manager, EHS

Indianapolis, IN · On-site

$79K - $107K/yr

Lead investigations of incidents, near-misses, injuries, spills, and environmental events; manage root cause and CAPA. * Develop and maintain EHS training (onboarding, annual refreshers, role ...

Boston Scientific

Quality Engineer III

Spencer, IN · On-site

$61K - $80K/yr

Experience interacting with manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering functions. Proficiency with Microsoft Office ...

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Capa Manager information

See Indiana salary details

$12

$37

$54

How much do capa manager jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for capa manager in Indiana is $37.67, according to ZipRecruiter salary data. Most workers in this role earn between $28.62 and $44.39 per hour, depending on experience, location, and employer.

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What are popular job titles related to Capa Manager jobs in Indiana?

For Capa Manager jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Capa Manager jobs in Indiana look for?

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Capa Manager jobs near you
Infographic showing various Capa Manager job openings in Indiana as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 79% Physical, 4% Hybrid, and 17% Remote job distribution, with an average salary of $78,363 per year, or $37.7 per hour.

Quality & Regulatory Specialist

Batesville, IN • On-site

Med Mizer Inc
See more jobs at Med Mizer Incexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing
Company Overview
Med-Mizer is a leading manufacturer of hospital beds, specialty seating, and safe patient-handling solutions. Our mission is to provide high-quality, innovative products that enhance patient care and safety. We are seeking a hands-on Quality & Regulatory Specialist who can support and continuously improve our FDA QMSR & ISO 13485 Quality Management System to support our manufacturing operations. The ideal candidate will have a strong background in manufacturing quality systems and safety regulations. This position will work closely with the QA/RA Manager and operational teams to maintain a safe, compliant, and efficient work environment while supporting quality objectives throughout the organization.
Med-Mizer, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Position: Quality & Regulatory Specialist
Schedule: Monday - Friday 6:00am - 3:00pm
Key Responsibilities
Quality Management System (QMS)
  • Manage and maintain the FDA QMSR / ISO 13485 Quality Management System.
  • Ensure compliance with all applicable regulatory and customer requirements.
  • Oversee document control and record retention processes.
  • Coordinate Management Review activities and present quality system performance metrics.
  • Ensure quality objectives are established, monitored, and achieved.
  • Maintain inspection readiness and audit preparedness.

CAPA and Nonconformance Management
  • Lead the Corrective and Preventive Action (CAPA) program.
  • Ensure timely investigation and closure of quality issues.
  • Facilitate root cause investigations.
  • Monitor effectiveness of corrective actions.
  • Manage nonconforming product processes and disposition activities.

Risk Management
  • Ensure risk management activities comply with ISO 14971 requirements.
  • Participate in risk assessments associated with products, processes, equipment, and suppliers.
  • Support implementation of risk controls and verification of effectiveness.
  • Ensure risk management files remain current and complete.

Validation and Quality Engineering Support
  • Review and approve validation protocols and reports.
  • Support process improvement and process capability initiatives.
  • Ensure manufacturing changes are properly evaluated and validated.

Internal Audits and Regulatory Inspections
  • Manage the internal audit program.
  • Coordinate external audits, customer audits, certification audits, and regulatory inspections.
  • Track audit findings through closure.

Supplier Quality Management
  • Ensure supplier qualifications and monitoring programs meet ISO 13485 requirements.
  • Manage supplier audits and supplier performance reviews.
  • Oversee supplier corrective action requests (SCARs).
  • Support supplier risk assessments and change management.

Customer Quality and Complaint Handling
  • Manage customer complaint investigations.
  • Ensure complaint-handling processes meet applicable regulatory requirements.
  • Analyze customer quality trends and implement improvement actions.
  • Serve as primary escalation point for customer quality issues.

Training and Quality Culture
  • Ensure employee training programs meet regulatory and quality requirements.
  • Verify personnel competency for quality-critical tasks.
  • Promote quality awareness throughout the organization.
  • Support continuous improvement initiatives across all departments.

Success Measures
  • Successful maintenance of ISO 13485 implementation
  • Timely closure and effectiveness of CAPAs
  • Reduction in customer complaints and internal quality issues
  • Successful completion of internal, customer, and certification audits
  • Supplier quality performance improvements
  • On-time completion of Management Reviews and Quality Objectives

Qualifications
Preferred Background
  • Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related field.
  • 3+ years of progressive quality experience in a regulated manufacturing environment.
  • 3+ years working with ISO 13485 Quality Management Systems.
  • Experience leading internal, customer, and certification audits.
  • Strong knowledge of CAPA, nonconformance management, change control, complaint handling, and supplier quality.
  • Experience in FDA-regulated medical device manufacturing is highly preferred.

Technical Expertise: demonstrated experience with:
  • FDA QMSR / ISO 13485
  • CAPA systems
  • Internal auditing
  • Risk management (ISO 14971 preferred)
  • Supplier qualification and supplier corrective actions
  • Validation activities (IQ/OQ/PQ)
  • Complaint investigations
  • Document control and change management

Physical Requirements
  • Primarily office-based with time spent in manufacturing environments.
  • Ability to walk production floors as needed to support quality and regulatory systems.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation & Benefits
  • Competitive salary (exempt position)
  • Annual bonus program
  • Three weeks of paid vacation
  • Ten paid holidays per year
  • Health, Dental, Vision, and Life Insurance (immediate eligibility)
  • Health Savings Account (HSA) option
  • 401(k) retirement plan options
  • Family owned and growing company environment

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