Quality Assurance Compliance Auditor - (US-NJ-Mahwah)

Quality Assurance Compliance Auditor - (US-NJ-Mahwah)

Compensation: $60K - $75K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: S8138BRJA

If not you, would you know someone???  I will pay a finders' fee if you refer someone who is hired.

Experience Required : 3 - 5 years

OB DESCRIPTION:# 1. 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.2. Ensures effective and timely audit closure of all nonconformities cited during audits. Create formal audit reports and assign corrective action-as appropriate.ESSENTIAL DUTIES AND RESPONSIBILITIES:# 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 nonconformities 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 Business Process Excellence initiative.

Candidate Must Have :
* 3-8 years auditing experience in medical device or other regulated industry.
* Project Management experience.
* PC Proficiency
* Strong organizational and written/verbal communication skills
* Internal or lead auditor certification (CQA/CQE) required

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume.

NO RELOCATION. NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.

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Jeff Altman, The Big Game Hunter
Concepts In Staffing
9 East 37 Street
New York, NY 10016