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 Compliance Auditor - Medical Device

Details
Country: USA
Location: Pennsylvania-Erie Statewide, PA
Total applied: 6
Compliance Auditor - Medical Device

Description Global Medical Device manufacturer,experiencing extraordinary growth has an immediate need for a Compliance Auditor. Desirable compensation and benefits. Searching for a candidate with an excellent track record in the field of medical devices. Under direction of the Regulatory Compliance Manager, position's primary responsibility is to conduct internal and external compliance audits of the facility and suppliers. Review suppliers proposed corrective actions to audit observations. Conduct internal audits to assess the facility's state of compliance to the FDA Regulations, ISO 9001 and ISO 13485. Generate internal audit reports for communication of observations to management. Maintain up-to-date knowledge of FDA regulatory requirements, ISO 9001 and ISO 13485. Act as a consultant for determination of appropriate corrective and preventive actions to address internal audit observations. Provide local site regulatory training for all employees.RequirementsBachelor's Degree in technical, scientific or business fields required. Minimum of 5 years quality/compliance in the medical device and/or pharmaceutical industry. Apply only if you have experience in these fields! Minimum of 3 years experience as an internal and external auditor/lead auditor of GMP QSReg,ISO 9001, and ISO 13485 requirements for internal audits, and supplier audits. Experience in FDA establishment inspections and ISO inspections is highly desirable. MUST HAVE EXPERIENCE IN THE MEDICAL DEVICE OR PHARMACEUTICAL INDUSTRY.TO BE CONSIDERED, PLEASE E-MAIL YOUR RESUME TO US IN WORD DOC FORMAT.THANK YOU! MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Statewide, PA JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee SALARY: 65,000.00 - 80,000.00 USD /yearBONUS JOB REFCODE: 2133 CONTACT NAME: Darrell

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