Internal Quality Systems Auditor — FDA/ISO, 6-Month Role

Connexion Systems & Engineering Inc.; Providence (RI); On-site; USD 48,000 - 59,000; Full time

Job summary

Connexion Systems & Engineering Inc. is seeking an Internal Quality Systems Auditor in Providence, RI. The role focuses on ensuring quality systems, supplier controls, and processes meet FDA, ISO, client, and internal requirements.

You will plan and conduct audits, evaluate supplier compliance, and document findings with actionable remediation plans. Some travel may be required to supplier and client sites as part of audit coverage.

Qualifications

• Bachelor's degree in scientific, engineering, quality, regulatory, or related discipline preferred.
• ISO 13485:2016 lead auditor certificate required.
• Experience in FDA-regulated medical device environments is essential.

Responsibilities

• Plan, schedule, conduct, and report internal quality system audits.
• Perform supplier/vendor audits to evaluate regulatory and contractual compliance.
• Evaluate effectiveness of quality management systems through audits.
• Prepare audit plans, checklists, and executive summaries.
• Document audit observations, nonconformances, risks, and improvement opportunities.
• Present findings to management, clients, suppliers, and cross-functional teams.
• Coordinate audit logistics and maintain audit records.

Skills

Auditing

Regulatory knowledge

Documentation

Cross-functional teamwork

Education

Bachelor's degree in a relevant field

ISO 13485 lead auditor certificate

Job description

Connexion Systems & Engineering Inc. is seeking an Internal Quality Systems Auditor in Providence, RI. The role focuses on ensuring quality systems, supplier controls, and processes meet FDA, ISO, client, and internal requirements.

You will plan and conduct audits, evaluate supplier compliance, and document findings with actionable remediation plans. Some travel may be required to supplier and client sites as part of audit coverage.