Quality Engineer III
CryoLife - Kennesaw, GA

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

Position Summary

Utilize Quality Engineering techniques and practices to ensure that raw materials, components and tissue(s)/ product(s) received, tested, processed, stored and distributed by CryoLife comply with all applicable international, federal, industry and corporate regulations, guidelines and procedures for validation and calibration.

Responsibilities

  • Coordinate validation aspects of corporate projects.
  • Develop Validation Master Plans to ensure all necessary validation work for corporate projects is addressed in a timely fashion.
  • Design, prepare, execute, and analyze Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), and Process Validations (PVs) to approve equipment, processes, and software used in the receipt, testing, processing, storage and distribution of raw materials, components and tissue(s)/product(s).
  • Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and QSR/ISO compliance by establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures.
  • Provide Quality Engineering support in resolving supplier-related quality issues and assist in the evaluation of tissue/product complaints.
  • Develop, conduct, and document qualifications/validations to ensure that the tissue(s)/product(s) processed are proven to be reliable, safe, and effective prior to release.
  • Collect, statistically analyze and develop report packages to support all qualifications/ validations.

Requirements

  • Minimum of a Bachelor's degree in an Engineering or Science field or equivalent work experience.
  • Minimum of 5 years of hands-on validation experience, preferably in a pharmaceutical, biomedical or medical device field(FDA regulated industry) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations and ISO Standards.
  • Experience designing, preparing, executing and statistically analyzing IQs, OQs, PQs and PVs, developing Validation Master Plans and Validation Project Plans and developing report packages to approve equipment, processes and software used in the receipt, testing, processing, storage and distribution of raw materials, components and tissue(s)/product(s).
  • Specific experience preferred in the areas of sterilization of equipment and processes for gamma, ETO and steam, HVAC systems, USP Purified and WFI systems and Validation Master Planning.
  • Specific experience developing and executing software validation protocols, specifically for custom Lotus Notes databases and SAP, preferred.
  • Preferably have ASQ CQE certification but is not required.
  • Computer skills including word processing, spreadsheets and data analysis.
  • Excellent written and verbal communication skills and good interpersonal skills.
  • Ability to effectively manage and prioritize numerous projects and responsibilities.

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 through CryoLife's website.
Copy and paste the following website into your internet browser.
http://bit.ly/CryoLifeQualityEngineerIII


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