Compliance Auditor
CryoLife - Kennesaw, GA

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Position Summary
Employment Type: Employee - Full time
Work Schedule: 8:30 a.m. to 5:30 p.m., Monday - Friday
Travel: 50% of the time, including international travel

Plan, schedule and perform both internal and external compliance audits. Prepare comprehensive audit reports and ensure timely and effective follow-up on the audit observations. Assist management with the maintenance of the Corrective and Preventive Action Program (CAPA).

Responsibilities

  • Assist management with the implementation of policies, procedures and practices as they relate to Good Tissue Practices, Quality System Regulations, ISO Standards, AATB Standards and other applicable Industry Standards.
  • Assist with any outside compliance assessments, both on-site and through the completion of surveys, such as FDA, ISO, International Regulators, etc.
  • Participate in the Supplier Quality Program by planning, conducting and reporting supplier quality audits.
  • Ensure that the quality system compliance programs being audited are consistent with and compliant to recognized standards and regulatory requirements, apprising management of the audit findings and initiating discussions with appropriate personnel to resolve any issues.
  • Perform audits for internal programs to assure compliance with the established quality system, industry standards, regulatory requirements and legal obligations.
  • Develop audit schedules, review and report findings, analyze audit data for critical trend analysis and assist in the development of CAPA plans.
  • Ensure that all non-conformances identified are addressed in a timely manner, appropriate root cause and corrective actions are identified and completed.
  • Support the creation, revision and approval of Standard Operating Procedures (SOPs) related to compliance.

Requirements

  • Bachelor's degree, preferably in the Life Sciences or an equivalent field of study.
  • Minimum of 3 years of auditing experience in a regulated industry with knowledge of ISO, FDA and Quality System Regulations.
  • Experience performing supplier quality audits.
  • Must have ability and willingness to travel 50% of the time, including international travel.
  • Strong computer skills, including word processing, spreadsheets and general data analysis.
  • Ability to prioritize, manage and follow up on numerous projects and activities.
  • Effective communication skills, both written and verbal.
  • Ability to handle sensitive and/or confidential information in the appropriate manner.

In order to be considered for this position, you must apply directly to CryoLife.
Copy and paste the following website into your internet browser.
http://bit.ly/CryoLifeComplianceAuditor

Company Overview

CryoLife is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company, using its proprietary SynerGraft® technology processes the CryoValve® SG pulmonary heart valve and CryoPatch® SG pulmonary cardiac patch, both of which have FDA 510(k) clearance for specific indications. The Company's BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue® is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair and was recently approved in Japan for use in the repair of aortic dissections. The Company's BioFoam® Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. CryoLife distributes PerClot®, an absorbable powder hemostat, in the European Community. CryoLife, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of cardiovascular disease and the sale of devices that treat severe Angina. Its market leading FDA-approved Holmium: YAG laser system and single use fiber-optic delivery systems are used to perform a surgical procedure known as Transmyocardial Revascularization (TMR). In addition, CryoLife's subsidiary Hemosphere, Inc. markets the HeRO Graft, which is a solution for end-stage renal disease in certain hemodialysis patients. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of northwest Atlanta.
CryoLife is an Equal Opportunity Employer.

In order to be considered for this position, you must apply directly to CryoLife.
Copy and paste the following website into your internet browser.
http://bit.ly/CryoLifeComplianceAuditor


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About this company
CryoLife is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries...