Quality Assurance Compliance Auditor

LOCATION: Mahwah, NJ Qualifications: Bachelor's Degree required. Internal or lead auditor certification (CQA/CQE) required. Years of relevant experience: 3-8 years auditing experience in medical device or other regulated industry. Percent Travel Required:  5% Job Description: Performs internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance. Ensures effective and timely audit closure of all nonconformities cited during audits. Create formal audit reports and assign corrective action-as appropriate. Key Attributes of the Candidate: 3-8 years auditing experience in medical device or other regulated industry. Project Management experience. PC Proficiency. Strong organizational and written/verbal communication skills. Self-motivated with the ability to effectively work with others in various coordinate disciplines, on multi-national teams, and to prioritize tasks in a deadline-driven environment. Principal Accountabilities:  Performs internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance. Perform external quality assurance audits on new and existing suppliers to ensure compliance to corporate requirements. Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited during audits. Create formal audit reports and assign associated corrective actions. Develop/modify audit checklists as regulatory requirements change. Present internal audits findings quarterly at management review meetings. Develop and conduct effective training programs on related QA topics. Conduct and support benchmarking activities. Identify areas of opportunity and support continual improvement of the Quality Management System. Identify, develop, and report QMS metrics. Participation in continuous (breakthrough) improvement activity and process re-engineering projects in support of company Business Process Excellence initiative. Management Recruiters of Wrightsville Beach (The Port City Group, Inc.) is an executive search and recruitment firm specializing in medical device, pharmaceutical and biotechnology industries.   ALL RESUMES REMAIN CONFIDENTIAL.  Qualified candidates, please send WORD resume, cover letter highlighting strengths for the position and daytime phone number to:  Martha Barrett, barretthr@bellsouth.net .  MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Mahwah, NJ 07430 JOB CATEGORY: Quality Assurance/Safety TYPE: Full Time, Employee SALARY: Bonus, Relo JOB REFCODE: QA Auditor MB COMPANY: MRINetwork EMAIL: Apply by Email