ISO 13485 Lead Auditor

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🔥 1 hour ago

🏈 Ohio – Remote

🏈 Ohio – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

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Smithers

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

🏭 Manufacturing

Consulting • Healthcare • Manufacturing

Smithers is a global B2B provider of scientific testing, inspection, certification, advisory and market-intelligence services. The company operates laboratories and consultancy teams that perform materials and product testing, regulatory and quality management certification (ISO, AS, CMMC, etc. ), audits, and technical training for industries such as pharmaceuticals, medical devices, aerospace, automotive, packaging, consumer goods and energy. Smithers also produces market reports, conferences and events to deliver industry insights and support clients across complex supply chains.

📋 Description

• Conduct audits to evaluate medical device quality management systems for conformity with ISO 13485 and applicable regulatory requirements • Prepare audit plans, review client documentation, and assess readiness for certification activities • Perform assessments of client facilities, processes, and quality management systems to determine compliance with certification requirements • Evaluate documented information, operational processes, and quality system implementation to verify management system effectiveness • Identify and document nonconformities, observations, and opportunities for improvement • Maintain complete and accurate audit records in accordance with accreditation requirements and internal procedures • Submit expense reports and other critical audit documentation within established timelines • Maintain acquired auditor credentials • Build positive relationships with clients while providing quality auditing and exceptional client services • Support accurate, timely, and high-touch certification services for medical device manufacturers and related organizations

🎯 Requirements

• Experience auditing medical device quality management systems across documentation review, medical device risk management, implementation audits, and audit reporting • Participation as a trainee in at least four audits totaling at least 20 days in an accredited QMS program • At least 50% of trainee audit experience must be against ISO 13485 • Remaining trainee audit experience may be in another accredited QMS program • Audit team leaders must have completed the Audit Team Leader role under a qualified Lead Auditor for at least three ISO 13485 third-party certification audits • Maintain acquired auditor credentials • Maintain a high level of integrity and impartiality • For full-time opportunities: variable salary commensurate with experience and work efficiency

🏖️ Benefits

• Medical, dental, and vision benefit plan • 401(k) retirement savings plan • Life insurance and AD&D • Short-term and long-term disability coverage • Wellness Program • Employee Assistance Program (EAP) • Business Operation System (BOS) – SQA Audit Management Platform • Training and development support • Flexible work schedule • Assignment priority