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Capa Jobs in Indiana (NOW HIRING)

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

Support CAPA verification of effectiveness (VOE) activities. * Tracking, trending, and monitoring Quality key performance indicators (KPIs). * Report quality KPIs to Quality Review Board (QRB)

Corrective and preventive actions (CAPA) * Develop remediation plans and evaluate training effectiveness. LMS Administration * Manage LMS course configuration and curricula. * Maintain training ...

You will publish Metric Trending Plans for Calibration. Assist with Corrective and Preventive Action (CAPA) resolution * You will assists with revising Operational Procedures and Continuous ...

Track corrective and preventive actions (CAPA) and verify effectiveness as required. Assist with risk assessments and process improvement initiatives. AIB Food Safety, GMP Compliance,and FDA Support ...

Manufacturing Engineer

Warsaw, IN · On-site

$70K - $90K/yr

Completes activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with client Corporate CAPA system . Completes activities of Lean Sigma projects and ...

Showing results 21-40

Capa information

See Indiana salary details

$13

$39

$66

How much do capa jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for capa in Indiana is $39.53, according to ZipRecruiter salary data. Most workers in this role earn between $29.97 and $45.97 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 Indiana?

The most popular types of Capa jobs in Indiana are:

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

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

Infographic showing various Capa job openings in Indiana as of August 2026, with employment types broken down into 88% Full Time, 5% Part Time, 6% Contract, and 1% Nights. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution, with an average salary of $82,223 per year, or $39.5 per hour.

Quality Engineer

Ambu

Noblesville, IN • On-site

$67K - $87K/yr

Full-time

Re-posted 20 days ago


Job description

Quality Engineer
City: Noblesville
Country/Region: United States
State: Indiana
Business Area: Quality Assurance
Department: QA, Noblesville
Employment Type: Full-time
Req ID: 9887
We are seeking a Quality Engineer with experience in medical device design quality and risk management to support product development from concept through commercialization. This role will primarily support R&D and Process Engineering activities to ensure compliance with design controls and risk management requirements.
The ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem-solving methodologies, and a solid understanding of ISO 13485, 21 CFR 820, and ISO 14971 requirements to identify and mitigate potential compliance, product and patient safety risks.
Objective:
The objective of this position is to provide the level of resource necessary to maintain, monitor and improve the Quality Management System (QMS) for Ambu USNV, to ensure compliance with regulatory requirements and established local and Corporate practices.
Responsibilities and Essential Functions (Applicable to all positions listed above):
  • Identify and implement effective quality control systems to support on-going manufacturing and product/process development activities to meet internal and customer requirements.
  • Assist in the improvement and streamlining of quality practices across the organization to effectively identify and resolve quality issues.
  • Apply sound and systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Responsible for product and process risk management activities.
  • Support the review, investigation, resolution and prevention of product and process nonconformances (NCRs) to meet established internal requirements.
  • Develop rework procedures to support NCR activities.
  • Act as a handler for Corrective Actions/Preventive Actions (CAPA) system activities to drive proper risk evaluation, investigation, and implementation of actions.
  • Support CAPA verification of effectiveness (VOE) activities.
  • Tracking, trending, and monitoring Quality key performance indicators (KPIs).
  • Report quality KPIs to Quality Review Board (QRB).
  • Participate in CAPA Review Board (CRB) meetings, as necessary.
  • Review calibrations out of tolerance assessments (OOTAs) and support with calibration remedial actions reports (RARs).
  • Responsible for change control activities related to quality documentation, such as updates to procedures, instructions, forms, risk management documentation, etc.
  • Quality functional approver for product and process changes as a subject matter expert (SME) of assigned areas.
  • Support Document Controls activities, as necessary.
  • Develop new and/or improve quality documentation (procedures, instructions, forms, ect.).
  • Write and execute spreadsheet validation documentation, as necessary.
  • Provide quality engineering support to process improvements and product/process development projects to ensure implementation of highest quality solutions.
  • Support complaint investigations, as necessary.
  • Become part of the internal auditing team as a certified auditor.
  • Supporting backroom activities during external audits, as necessary.
  • Provide guidance to less experienced staff.
  • Perform other related duties and responsibilities, as assigned.

Responsibilities and Essential Functions - Engineer II, Quality:
  • 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 streamline quality practices across the organization to improve QMS efficiency and maintain its effectiveness.
  • Lead and provide guidance to the rest of the organization in proper root cause investigation techniques.
  • Provide guidance on the use of statistical techniques for selection of sampling strategies and analysis of data.
  • Facilitate CRB, QRB, and Management Review meetings.
  • Responsible for data trending and preparation for Management Reviews and Corporate Management Reviews.
  • Write and execute Test Method Validation (TMV) documentation related to Quality Assurance inspection methods, as necessary.

Qualifications:
Level: Engineer
  • Bachelor's degree in Engineering or technical field equivalent experience.
  • 1 - 2 years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.

Level: Engineer II
  • Bachelor's degree in Engineering or technical field equivalent experience.
  • 2 - 5 years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.
  • Working technical knowledge and application of quality concepts, practices, and procedures.

Required skills:
  • Experience with ISO 13485 and/or 21 CFR Part 820.
  • Ability to travel nationally and internationally up to approximately 5% of a year's time.
  • Good attention to detail and organizational skills.
  • Proficient at applying analytical and problem-solving tools and methodologies.
  • Ability to work, interact, and communicate effectively with others.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Effective verbal and written communication skills.
  • Great technical writing skills.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint).
  • Must be able to read, write and understand English.

Preferred skills:
  • Auditor or Lead Auditor certification.
  • Experience with EU MDR 2017/745.
  • Experience with ISO 14971.

Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.

Ambu logo

About Ambu

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

501 - 1,000 Employees

Headquarters location

Noblesville, IN, US

Year founded

1937