Validation Engineer
Chicago, IL · On-site
QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER our client is looking to hire 15-20 people Will ... CAPA, Risk Management, and CE Technical Files. · Direct and collaborate with supplier ...
Chicago, IL · On-site
QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER our client is looking to hire 15-20 people Will ... CAPA, Risk Management, and CE Technical Files. · Direct and collaborate with supplier ...
Chicago, IL · On-site
QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER our client is looking to hire 15-20 people Will ... CAPA, Risk Management, and CE Technical Files. · Direct and collaborate with supplier ...
Chicago, IL · On-site
$74K - $95K/yr
... CAPA, Risk Management, and CE Technical Files. · Direct and collaborate with supplier ... Education: · Bachelor's degree in Engineering, Science, Math or other related technical field.
Chicago, IL · On-site
$74K - $95K/yr
... CAPA, Risk Management, and CE Technical Files. · Direct and collaborate with supplier ... Education: · Bachelor's degree in Engineering, Science, Math or other related technical field.
Buffalo Grove, IL · On-site
$55 - $65/hr
Support CAPA investigations, change control activities, and regulatory audits. Work cross-functionally with Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs teams.
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Buffalo Grove, IL · On-site
$55 - $65/hr
Support CAPA investigations, change control activities, and regulatory audits. Work cross-functionally with Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs teams.
Title : Quality Assurance Engineer Location : Near Crystal Lake, IL Hire Type : Direct Hire ... Lead CAPA, complaint investigations, audits, and Quality Management System activities.
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Title : Quality Assurance Engineer Location : Near Crystal Lake, IL Hire Type : Direct Hire ... Lead CAPA, complaint investigations, audits, and Quality Management System activities.
Des Plaines, IL · On-site
$78 - $156/hr
Senior Manufacturing Engineer Des Plaines, IL - Abbott Molecular Diagnostics Senior Manufacturing ... Execute CAPA related actions and action plans. Execute investigations and document via CAPA ...
Des Plaines, IL · On-site
$78 - $156/hr
Senior Manufacturing Engineer Des Plaines, IL - Abbott Molecular Diagnostics Senior Manufacturing ... Execute CAPA related actions and action plans. Execute investigations and document via CAPA ...
Buffalo Grove, IL · On-site
$80 - $115/hr
Quality Engineer - Medical Devices job at Intellectt Inc., Buffalo Grove, IL. Role: Quality ... Lead and manage Quality Assurance (QA) systems, including CAPA, audits, and compliance. * Ensure ...
Buffalo Grove, IL · On-site
$80 - $115/hr
Quality Engineer - Medical Devices job at Intellectt Inc., Buffalo Grove, IL. Role: Quality ... Lead and manage Quality Assurance (QA) systems, including CAPA, audits, and compliance. * Ensure ...
Chicago, IL · On-site
$28 - $37/hr
Quality Engineer **Location: Chicago,Illinois** Duration: Direct Hire/Full Time We are seeking a ... Knowledge of PPAP, SPC, CAPA, and Root Cause Analysis . * Experience using calipers, micrometers ...
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Chicago, IL · On-site
$28 - $37/hr
Quality Engineer **Location: Chicago,Illinois** Duration: Direct Hire/Full Time We are seeking a ... Knowledge of PPAP, SPC, CAPA, and Root Cause Analysis . * Experience using calipers, micrometers ...
Chicago, IL · On-site
$28 - $37/hr
Quality Engineer **Location: Chicago, Illinois ** Duration: Direct Hire/Full Time We are seeking a ... Knowledge of PPAP, SPC, CAPA, and Root Cause Analysis . * Experience using calipers, micrometers ...
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Chicago, IL · On-site
$28 - $37/hr
Quality Engineer **Location: Chicago, Illinois ** Duration: Direct Hire/Full Time We are seeking a ... Knowledge of PPAP, SPC, CAPA, and Root Cause Analysis . * Experience using calipers, micrometers ...
Support CAPA investigations, change control, and regulatory audits * Work cross-functionally across Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs What You Bring
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Support CAPA investigations, change control, and regulatory audits * Work cross-functionally across Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs What You Bring
Buffalo Grove, IL · On-site
$38.46 - $40.87/hr
Job Summary Our client is seeking a Quality Engineer responsible for executing customer-related ... Apply hands-on experience in CAPA and Production Pre-Approval processes. Qualifications * BS Degree ...
Buffalo Grove, IL · On-site
$38.46 - $40.87/hr
Job Summary Our client is seeking a Quality Engineer responsible for executing customer-related ... Apply hands-on experience in CAPA and Production Pre-Approval processes. Qualifications * BS Degree ...
Crystal Lake, IL · On-site
$80K - $85K/yr
Lead and support CAPA processes, including root cause analysis and corrective actions * Develop ... Support change management and engineering changes * Ensure products are manufactured to design ...
Crystal Lake, IL · On-site
$80K - $85K/yr
Lead and support CAPA processes, including root cause analysis and corrective actions * Develop ... Support change management and engineering changes * Ensure products are manufactured to design ...
Chicago, IL · On-site
$75 - $110/hr
Lead or facilitate root cause analysis and corrective/preventive actions (RCA/CAPA) using ... Bachelor's degree in Engineering or related technical field. * 3+ years of experience in a Quality ...
Chicago, IL · On-site
$75 - $110/hr
Lead or facilitate root cause analysis and corrective/preventive actions (RCA/CAPA) using ... Bachelor's degree in Engineering or related technical field. * 3+ years of experience in a Quality ...
Naperville, IL · On-site
$40 - $45/hr
Bachelor's degree in engineering required. * 2-4 years of experience required. * Previous ... Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non ...
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Naperville, IL · On-site
$40 - $45/hr
Bachelor's degree in engineering required. * 2-4 years of experience required. * Previous ... Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non ...
Waukegan, IL · On-site
$68K - $88K/yr
Job Title: Quality Engineer The Quality Engineer develops, implements, and maintains quality ... Experience implementing and managing corrective and preventive actions (CAPA) and corrective action ...
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Waukegan, IL · On-site
$68K - $88K/yr
Job Title: Quality Engineer The Quality Engineer develops, implements, and maintains quality ... Experience implementing and managing corrective and preventive actions (CAPA) and corrective action ...
Lincolnshire, IL · On-site
$45/hr
Mechanical Engineer Duration: 6 Months Location: 3 Overlook Point, Lincolnshire, IL Interview ... CAPA). Design Improvements: -Recommend and implement design enhancements to improve product ...
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Lincolnshire, IL · On-site
$45/hr
Mechanical Engineer Duration: 6 Months Location: 3 Overlook Point, Lincolnshire, IL Interview ... CAPA). Design Improvements: -Recommend and implement design enhancements to improve product ...
Overview The Engineering Process Manager, Software serves as the independent quality governance ... CAPA & Continuous Improvement * Own Corrective and Preventive Action (CAPA) governance processes.
Overview The Engineering Process Manager, Software serves as the independent quality governance ... CAPA & Continuous Improvement * Own Corrective and Preventive Action (CAPA) governance processes.
Cary, IL · On-site
$73K - $94K/yr
The Role: As the Quality Engineer (QE), youwill provide quality engineering and direct customer ... Lead Quality System maintenance activities, such as CAPA, Complaints, and audits. * Leads quality ...
Cary, IL · On-site
$73K - $94K/yr
The Role: As the Quality Engineer (QE), youwill provide quality engineering and direct customer ... Lead Quality System maintenance activities, such as CAPA, Complaints, and audits. * Leads quality ...
Itasca, IL · On-site
Lead root cause investigations, CAPA activities, and process improvement initiatives. * Support new ... What You'll Bring: * BS in Engineering or related technical discipline. * 5+ years of experience in ...
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Itasca, IL · On-site
Lead root cause investigations, CAPA activities, and process improvement initiatives. * Support new ... What You'll Bring: * BS in Engineering or related technical discipline. * 5+ years of experience in ...
Crystal Lake, IL · On-site
$80K - $85K/yr
Lead and support CAPA processes, including root cause analysis and corrective actions * Develop ... Support change management and engineering changes * Ensure products are manufactured to design ...
Crystal Lake, IL · On-site
$80K - $85K/yr
Lead and support CAPA processes, including root cause analysis and corrective actions * Develop ... Support change management and engineering changes * Ensure products are manufactured to design ...
Lake Forest, IL · On-site
Must know Design Controls, Product Development and CAPA investigations. * Must be able to create protocols and reports. Strong communication skills required. Qualifications * B.S. in Engineering or ...
Lake Forest, IL · On-site
Must know Design Controls, Product Development and CAPA investigations. * Must be able to create protocols and reports. Strong communication skills required. Qualifications * B.S. in Engineering or ...
$40.2K - $49.4K
3% of jobs
$49.4K - $58.6K
3% of jobs
$58.6K - $67.8K
4% of jobs
$67.8K - $77.1K
7% of jobs
$77.1K - $86.3K
6% of jobs
$87.1K is the 25th percentile. Wages below this are outliers.
$86.3K - $95.5K
6% of jobs
The median wage is $103.8K / yr.
$95.5K - $104.7K
21% of jobs
$104.7K - $114K
4% of jobs
$120K is the 75th percentile. Wages above this are outliers.
$114K - $123.2K
29% of jobs
$123.2K - $132.4K
2% of jobs
$132.4K - $141.6K
13% of jobs
$40.2K
$104.8K
$141.6K
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.
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.
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.
The most popular types of Capa Engineer jobs in Chicago, IL are:
For Capa Engineer jobs in Chicago, IL, the most frequently searched job titles are:
The top searched job categories for Capa Engineer jobs in Chicago, IL are:

Chicago, IL • On-site
Other
Posted 5 days ago
QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER
our client is looking to hire 15-20 people
Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.
MAJOR RESPONSIBILITIES:
· Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files.
· Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
· Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
· Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
· Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
· Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
· Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
· Coordinate product testing with internal and external laboratories as required.
· Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
Education:
· Bachelor’s degree in Engineering, Science, Math or other related technical field.
Role Details:
· Work Schedule: Monday–Friday, 8:00am – 5:00pm
· Hybrid Work Model
o Monday & Friday: Remote
o Tuesday, Wednesday, Thursday: Onsite (no flexibility here) MUST be onsite these 3 days
· Location: Northfield, IL OR Chicago, IL
Candidate Qualifications:
· 2–5 years of Quality Engineering experience
· Medical device or pharmaceutical industry experience required
· Strong working knowledge of 21 CFR Part 820 and/or ISO 13485
· Handson experience with Device History Files (DHF) and CAPA
Experience supporting operations, investigations, and compliance activities in a regulated environmen
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51 - 200 Employees
San Jose, CA, US
1993