Internal Quality Systems Auditor

Connexion Systems + Engineering; 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

Job Title: Internal Quality Systems Auditor Pay Rate: $35-$43/hr.

Location: Providence, RI 02907, Duration: 6 months, high probably of TTP (this role is already budgeted as a FT hire)

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

Primary Responsibilities:

• 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.

Education/ Certificates:

• 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.

Preferred Qualifications:

• 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