Lead Auditor

Job Title - Lead Auditor Location - Franklin Lakes, NJ Duration - 4+ Months Work hours: 8am-5pm, 40 hours/week Client: Medical Device Company Job Category: Engineering Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Description: MUST HAVES • Verify and document evidence of compliance / non-compliance • Prepare audit report • Establish map of DHF document trace • Help populate Design Trace Matrix • Review audit results with key stakeholders • Assist with corrective actions The Auditor, Medical Devices will support the RD team by leading DHF assessment activities to ensure Design History File (DHF) readiness for launch of a key project. This role will require both on-site and home-based presence. DUTIES: • Act as lead auditor in assessing our medical device DHF for compliance with respect to internal Quality Systems and other relevant standards, specifically ISO 13485, ISO 14971 and/or GMP regulatory requirements related to the medical device. • Assist associates with questions relevant to the audit. • Act as Lead Auditor. • Coordinate audit activity with team members. • Review quality management system documentation • Verify and document evidence of compliance and non-compliance. • Prepare audit report. • Review audit results with key stakeholders and assessment team members. Generate presentations concerning audit results, when required. • Assist with corrective action requirements resulting from assessments. • Participate in audit meetings. • Review audit reports and provide technical assistance to the project team. REQUIREMENTS: • In-depth knowledge of auditing Design History Files in the medical device industry: • A minimum of 5+ years of full-time work experience in a medical device or related industry. • Certified in Lead Auditor training for ISO 13485. • Training in quality management systems and/or relevant regulatory requirements. • Strong communication and interpersonal skills. • Sound judgment, organizational, and analytical skills. • Excellent computer and writing skills. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Ability to exercise effective time management skills in completion of assignments.

Created: 2024-11-05