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# Internal Quality Systems Auditor

- **Company:** Connexion Systems & Engineering
- **Location:** Providence, RI, United States
- **Experience:** Experienced
- **Salary:** $72,800 - $89,440
- **Contract:** Temporary contract
- **Skills:** Data Auditing, Verification and Validation (Software), 21 CFR Part 820 Quality System Regulation
- **Published:** October 27, 2026
- **Apply:** https://jobs.csetalent.com/index.smpl?arg=jb_apply&POST_ID=14374933

## About the Role

* Bachelor's degree in scientific, engineering, quality, regulatory, or related discipline preferred. Equivalent combination of education and experience may be considered
 * ISO 13485:2016 lead auditor certificate required

Experience:

 * Minimum 3-5 years of experience in Quality Assurance, Quality Systems, Compliance, or Auditing within the medical device industry.
 * Experience conducting internal audits and supplier/vendor audits.
 * Experience working within FDA-regulated environments.

Strong knowledge of:

 * FDA 21 CFR Part 820
 * FDA 21 CFR Part 11
 * ISO 13485
 * Strong technical writing and report generation skills.
 * Excellent verbal and written communication skills.
 * strong organizational and project management skills.
 * ability to travel periodically for supplier, client, and internal audits., * 21 CFR Part 58
 * 21 CFR Part 14155
 * Risk Management principles (ISO 14971)
 * Experience supporting FDA inspections and notified body audits.
 * Experience auditing software validation and electronic quality systems subject to Part 11 requirements.
 * Experience with contract

## Description

Quality Systems Auditor: This role serves as a key quality compliance resource, ensuring that quality systems, suppliers, and processes consistently meet FDA, ISO, client, and internal quality requirements, * Plan, schedule, conduct, and report internal quality system audits in accordance with corporate internal auditing and local business unit audit programs

 * Perform qualification and requalification supplier/vendor audits to evaluate compliance with regulatory, quality, and contractual requirements.
 * Evaluate the effectiveness of quality management systems by way of performing directed and non-directed audits
 * Prepare comprehensive audit plans, checklists, reports, and executive summaries.
 * Document audit observations, nonconformances, risks, and opportunities for improvement.
 * Present audit findings to management, clients, suppliers, and cross-functional teams.
 * Maintain accurate audit records within designated quality systems.
 * Serve as a primary point of contact for audit-related communications with clients and vendors.
 * Coordinate audit logistics and schedules with internal and external stakeholders.
 * Facilitate discussions regarding audit findings, remediation plans, and compliance expectations.
 * Review and evaluate supplier responses to audit observations.
 * Support continuous improvement initiatives across the quality management system.
 * Analyze audit trends and metrics to identify systemic issues and improvement opportunities.
 * Collaborate with Quality Assurance, Regulatory Affairs, Operations, and Engineering teams to strengthen compliance and quality processes., Emily Donahue
Regional Recruiting Manager

 * Directs the recruitment efforts for both the Quincy, MA and Providence, RI branches.
 * Manages a distributed team of recruiting leads, individual contributor recruiters and account managers.
 * Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region.