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Capa Engineer Jobs in Indiana (NOW HIRING)

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

Participate in CAPA Review Board (CRB) meetings, as necessary. * Review calibrations out of ... Provide quality engineering support to process improvements and product/process development ...

avalign

Sr. Quality Engineer

Greenwood, IN · On-site

$84K - $113K/yr

Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes. * Primary quality representative for site supplier management and ...

Cork Medical, LLC

Quality Engineer I

Indianapolis, IN · On-site

$68K - $88K/yr

This role oversees quality metrics, CAPA programs, supplier management, and training initiatives ... Bachelor's degree in engineering or a related field is preferred. * Proven experience in quality ...

Integrated Resources INC

Manufacturing Engineer

Warsaw, IN · On-site

$70K - $90K/yr

Job title-Manufacturing Engineer Location - Warsaw IN Duration -8+ months (Possibility of extension ... Completes activities of the change control policy and Corrective and Preventive Action (CAPA ...

Stevanato Group S.p.A.

Quality Engineer

Fishers, IN · On-site

$100K - $110K/yr

Plan and perform regular audits of quality system and drive system improvements through the CAPA ... Collaborate with Operations and Engineering to ensure execution of the qualification and validation ...

Lancesoft INC

Engineer II/Manufacturing Engineer

Gary, IN · On-site

$35 - $43/hr

Engineer II/Manufacturing engineer- Shift 1 Location: Gary, IN 46406 (Onsite) Duration: 6+ Months ... Support production processes and project timelines * Assist with CAPA tasks and root cause analysis

Monitise

Quality Engineer

Indianapolis, IN · On-site

$68K - $88K/yr

Job Title Quality Engineer About your role: Join our Output Solutions team within Fiserv as a ... CAPA) using FMEA, 8D, VSM, and more advanced problemsolving to eliminate systemic issues and ...

Fiserv, Inc.

Quality Engineer

Indianapolis, IN · On-site

$68K - $88K/yr

Job Title Quality Engineer About your role: Join our Output Solutions team within Fiserv as a ... CAPA) using FMEA, 8D, VSM, and more advanced problem-solving to eliminate systemic issues and ...

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Capa Engineer information

See Indiana salary details

$37.1K

$96.8K

$130.8K

How much do capa engineer jobs pay per year?

As of Jun 20, 2026, the average yearly pay for capa engineer in Indiana is $96,824.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,900.00 and $110,900.00 per year, depending on experience, location, and employer.

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

To thrive as a CAPA Engineer, you need a solid background in quality engineering, root cause analysis, and process improvement, typically supported by a degree in engineering or a related technical field. Familiarity with CAPA management systems, quality standards such as ISO 13485 or ISO 9001, and tools like Six Sigma or FMEA is highly valuable. Strong problem-solving abilities, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure effective identification, documentation, and resolution of quality issues, helping organizations maintain regulatory compliance and deliver high-quality products.

What is a CAPA Engineer job?

A CAPA (Corrective and Preventive Action) Engineer is responsible for identifying, investigating, and resolving quality issues in manufacturing or engineering processes. They analyze root causes of defects, implement corrective measures, and develop preventive strategies to ensure compliance with industry regulations. CAPA Engineers work closely with cross-functional teams to improve product quality, streamline processes, and maintain regulatory compliance. They also document findings, track action plans, and support continuous improvement initiatives to reduce future risks.

What are the main daily responsibilities of a CAPA Engineer?

A CAPA Engineer's daily responsibilities typically include investigating potential or actual nonconformities, conducting root cause analyses, and developing corrective and preventive action plans to resolve and prevent future issues. They also collaborate closely with cross-functional teams such as manufacturing, quality assurance, and regulatory affairs to ensure solutions are practical and compliant with industry standards. Additionally, CAPA Engineers monitor the progress and effectiveness of implemented actions, prepare documentation for audits, and participate in continuous process improvement initiatives. This role is crucial for maintaining the highest quality standards and ensuring compliance in regulated industries such as medical devices or pharmaceuticals.

What are popular job titles related to Capa Engineer jobs in Indiana? For Capa Engineer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Capa Engineer jobs in Indiana look for? The top searched job categories for Capa Engineer jobs in Indiana are:
Capa Engineer jobs near you

Quality Engineer

Ambu

Noblesville, IN • On-site

$67K - $87K/yr

Full-time

Posted yesterday

Job description

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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.

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

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