Quality Systems Specialist: CAPA, Audits & SOPs

A Hiring Company; Indianapolis (IN); On-site; USD 52,000 - 76,000; Full time

Job summary

A Hiring Company is seeking a Quality Assurance Associate to independently perform quality functions within the Quality Department, overseeing document control, CAPA, audits, and complaint handling.

The role requires an Associates degree or equivalent plus 3–5 years in medical device manufacturing, with strong regulatory knowledge and skills in Word, Excel, and Outlook. Effective communication and training abilities are essential for cross-functional collaboration.

Qualifications

• Associates degree or equivalent; or 3–5 years related experience in medical device manufacturing.
• Proficient with ISO 13485, FDA regulations, and related quality systems.
• Ability to read, analyze, and interpret general business documents and regulations.
• Strong writing skills for reports, SOPs, and procedures.
• Effective presentation and communication with diverse stakeholders.
• Experience with Word, Excel, and Outlook for documentation and communication.
• Demonstrates time management and independent work habits.

Responsibilities

• Review customer complaints and CAPA cycles.
• Lead internal audit program and document control activities.
• Assist in SOP development, revision, and document control.
• Identify training needs and conduct QA-related training with the Quality Manager.
• Investigate nonconformances, root cause analysis, and corrective actions.
• Support QMS maintenance and data entry to sustain production schedules.

Skills

Regulatory knowledge

Report writing

Communication skills

Time management

Attention to detail

Analytical reading

Education

Associates degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

A Hiring Company is seeking a Quality Assurance Associate to independently perform quality functions within the Quality Department, overseeing document control, CAPA, audits, and complaint handling.

The role requires an Associates degree or equivalent plus 3–5 years in medical device manufacturing, with strong regulatory knowledge and skills in Word, Excel, and Outlook. Effective communication and training abilities are essential for cross-functional collaboration.