Quality Engineer

Aegis Worldwide; Indianapolis (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Aegis Worldwide in Indianapolis is seeking a Quality professional to support the Quality Management System (QMS) and ensure compliance with customer, company, and regulatory requirements.

In this role you will monitor product and process quality through inspections, audits, investigations, and data analysis, and you will help lead CAPA and nonconformance investigations to drive continuous improvement.

Qualifications

• Bachelor's degree or equivalent experience required.
• 1–2 years in quality assurance/quality engineering in manufacturing (medical device preferred).
• Knowledge of quality systems, CAPA, root cause analysis, audits, and continuous improvement.
• Strong analytical, problem-solving, communication, and organizational skills.
• Ability to work independently and collaboratively in a cross-functional manufacturing environment.

Responsibilities

• Support and maintain the Quality Management System (QMS) to ensure compliance with requirements.
• Monitor product and process quality through inspections, audits, investigations, and data analysis.
• Lead or support CAPA, nonconformance investigations, and root cause analysis.
• Develop, update, and maintain quality documents, procedures, and work instructions.
• Track quality metrics, identify trends, and suggest continuous improvement initiatives.
• Participate in internal and external audits and support regulatory compliance activities.
• Collaborate with cross-functional teams to improve manufacturing processes and product quality.
• Provide technical guidance and quality support for process improvements and new product initiatives.

Skills

Quality systems

CAPA

Root cause

Data analysis

Audits

Cross-functional

Problem solving

Communication

Education

Bachelor's degree in Engineering, Quality, or related field

Job description

• Support and maintain the Quality Management System (QMS) to ensure compliance with company, customer, and regulatory requirements.
• Monitor product and process quality through inspections, audits, investigations, and data analysis.
• Lead or support root cause analysis, corrective and preventive actions (CAPA), and nonconformance investigations.
• Develop, update, and maintain quality documentation, procedures, and work instructions.
• Track quality metrics, identify trends, and recommend continuous improvement initiatives.
• Participate in internal and external audits and support regulatory compliance activities.
• Collaborate with cross-functional teams to improve manufacturing processes and product quality.
• Provide technical guidance and quality support for process improvements and new product initiatives.

Qualification

• sBachelor's degree in Engineering, Quality, or a related technical field, or equivalent experience
• .1–2 years of experience in quality assurance, quality engineering, or a related manufacturing environment (medical device experience preferred)
• .Working knowledge of quality systems, CAPA, root cause analysis, audits, and continuous improvement methodologies
• .Strong analytical, problem-solving, communication, and organizational skills
• .Ability to work independently and collaborate effectively in a cross‑functional manufacturing environment