Senior Quality Engineer - NPI, CAPA & Compliance

Aegis Manufacturing & Engineering; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Aegis Manufacturing & Engineering is seeking a Quality Engineer in Indiana to lead manufacturing quality initiatives, develop inspection plans, and drive CAPA investigations across the product life cycle. The role supports audits, supplier quality, and continuous improvement through robust QA plans and process controls.

Ideal candidate has a BS in engineering and 5+ years of manufacturing experience, with knowledge of ISO 13485 and 21 CFR 820, GD&T, and statistical analysis to ensure product

Qualifications

• BS in engineering or equivalent with 5+ years manufacturing experience
• Experience with ISO 13485 and 21 CFR 820 requirements
• Ability to read blueprints and interpret GD&T
• Proficient in statistical analysis and problem-solving techniques to determine product acceptance and process capability

Responsibilities

• Provide quality leadership in manufacturing inspection plan development
• Lead validation planning and NPI transfer activities
• Support CAPA investigations and design changes throughout product lifecycle
• Act as main Quality Engineering contact for customers and projects
• Manage Non-Conforming Material Reports system and dispositions
• Support supplier management and supplier nonconformances
• Lead audits to maintain regulatory, customer and ISO/Avalign compliance
• Develop and implement quality assurance plans and process controls
• Recommend test methods and SPC procedures for product reliability
• Perform or guide testing and data analysis including capability studies and Gage R&R
• Interact with operations and engineering to align MRB processes

Skills

Root Cause Analysis

Statistical Analysis

Quality Systems

CAPA

Problem Solving

Education

BS in Engineering

Tools

GD&T

Blueprint Reading

Inspection Methods

Statistical Process Control

Job description

Aegis Manufacturing & Engineering is seeking a Quality Engineer in Indiana to lead manufacturing quality initiatives, develop inspection plans, and drive CAPA investigations across the product life cycle. The role supports audits, supplier quality, and continuous improvement through robust QA plans and process controls.

Ideal candidate has a BS in engineering and 5+ years of manufacturing experience, with knowledge of ISO 13485 and 21 CFR 820, GD&T, and statistical analysis to ensure product