Job Description
Job Title: Internal Quality Systems Auditor
Pay Rate: $35-$43/hr. Some flexibility DOE
Location: Providence, RI 02907,
Duration: 6 months, high probably of TTP (this role is already budgeted as a FT hire)
Summary:
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:
Pay Rate: $35-$43/hr. Some flexibility DOE
Location: Providence, RI 02907,
Duration: 6 months, high probably of TTP (this role is already budgeted as a FT hire)
Summary:
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.
- 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
- 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.
- 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
Numbers & Facts
| Location | Providence, RI |
| Industry | Staffing/Employment Agencies |
| Salary | $35–$43 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | https://www.csetalent.com/ |
About Company
Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity. Over the last 20 years Connexion has built the most admired team of staffing experts in the industry. We give back, change lives and offer unconditional support to the candidates we represent.
Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.
Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want
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