Associate I, Tissue Quality Assurance

CryoLife, Inc. currently has an opportunity for an Application Engineer in our corporate office in Kennesaw (NW Atlanta).

Founded in 1984, CryoLife, Inc. was the first biomedical company to commercially develop low temperature preservation of implantable human tissues for cardiac, vascular and orthapaedic surgical reconstruction. CryoLife also produces BioGlue Surgical Adhesive, which is FDA approved as an adjunct to sutures and staples for use in open surgical repair of large vessels. The Company's proprietary processes have dramatically improved and enhanced the lives of tens of thousands of patients.

Requirements
Will ensure that all donors accepted and tissues/products processed at CryoLife, Inc. are properly identified, controlled, and meet all required quality specifications and regulatory standards prior to release for distribution.
Will have the responsibility of delivering initial approval of all donors and human tissues/products for distribution from CryoLife, Inc.
Will ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner.

Essential functions include, but are not limited to:
Will review and recommend the initial disposition of donor records and tissue processing records.
Will review and recommend the disposition of all other records associated with the processing of tissue, including but not limited to manufacturing batch records.
Will ensure that donors received for processing are properly identified, controlled, and meet the required quality specifications and regulatory standards prior to release.
Will keep self, superiors, and associated informed of significant information, company policies and procedures, and will provide such information in a manner that others give support and willing cooperation.
Will handle assignments in the immediate jurisdiction and accept assignments outside the immediate area of responsibility.
Will develop systematic methods for completing work assignments to ensure timelines are met and personal job commitments are accomplished.
Will understand ISO requirements and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification, etc.
Will aid management in assuring that specifications, procedures and test methods are periodically reviewed for accuracy, validity and functionality, and when necessary, initiate the required changes.
Will aid management with training programs to ensure Quality personnel are informed of and effective to updated standards, procedures and specifications.
Will evaluate, recommend, and implement changes in inspection requirements to move toward self-inspection and quality ownership.
Will have the ability and interest in being on the job every day as required by current attendance policies.
Will effectively complete “other” functions that may be assigned.
REQUIREMENTS
CryoLife offers competitive pay and benefits, which include: Health, Dental, Life, 401(k), Stock Purchase Plan, Tuition Reimbursement, Vacation Days and 10 Paid Holidays.

To apply for this position, you must complete an online application at www.cryolife.com/employment/mainnew.htm and attach a resume in MS Word format. No phone calls or faxes please. All four panels of the application must be completely filled before you can submit your application. Do not leave any spaces blank. If it does not apply to you, please indicate n/a.

If you are unable to apply online, please apply at our corporate office at 1655 Roberts Blvd, NW, Kennesaw, GA or submit a cover letter and resume with salary requirements to jobs@cryolife. com.

NO AGENCY CALLS PLEASE.