Quality Systems Specialist - CAPA & Internal Audits

Vonco Products LLC; Indianapolis (IN); On-site; USD 52,000 - 78,000; Full time

Job summary

Vonco Products LLC is seeking a Quality Assurance professional to independently perform quality-related functions within the Quality Department. The role focuses on maintaining and monitoring quality systems, including document control, change control, CAPA, internal audits, and complaint handling.

The position requires an Associate degree or equivalent, 3–5 years of related experience in medical device manufacturing, and proficiency with ISO 13485 and FDA regulations.

Qualifications

• Experience with medical device quality systems is required.
• Ability to read, analyze, and interpret governmental regulations and standards.
• Ability to write reports, procedures, and business communications.
• Excellent communication skills with coworkers and supervisor.

Responsibilities

• Manages review cycle of customer complaints and CAPAs.
• Lead internal audit program.
• Assist in development and control of SOPs and related documents.
• Identify training needs and conduct QA-related training with Quality Manager.
• Facilitate nonconformance processes with timely investigations and root-cause analyses.
• Support maintenance of the Quality Management System.
• Support performance metrics for continual improvement.
• Assist with inspections, document reviews, and data entry to maintain production/quality timelines.

Skills

Regulatory knowledge

Technical writing

Data interpretation

Communication

MS Office proficiency

Education

Associate degree or equivalent

3–5 years related experience

Tools

MS Office Suite

Job description

Vonco Products LLC is seeking a Quality Assurance professional to independently perform quality-related functions within the Quality Department. The role focuses on maintaining and monitoring quality systems, including document control, change control, CAPA, internal audits, and complaint handling.

The position requires an Associate degree or equivalent, 3–5 years of related experience in medical device manufacturing, and proficiency with ISO 13485 and FDA regulations.