Quality Systems Engineer III

2 weeks ago

Kennesaw, United States CryoLife Full time
Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website,www.artivion.com.

Position Objective:

  • Responsible for operating the Quality Management System (QMS).
  • To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both internal and external assessments.
  • Lead internal audits and help manage external assessments.
  • Provide training and champion the Quality Management System.
  • To assure the Corrective and Preventive Action Program, and Audit Programs requirements comply with all applicable requirements and to keep management advised of the status of these programs.
  • To assist with management review, nonconformance oversight, quality planning, and change control.
  • To administer the electronic quality management system and perform gap analysis as identified.
Responsibilities:
  • Oversee effective implementation and maintenance of the Quality Management System throughout the company
  • Support corporate quality objectives and achieve those goals within budget.
  • Support management as needed with coordination of QSE tasks
  • Maintain Quality Procedures and ensure contents are appropriate for business; revise as needed
  • Coordinate corrective and preventive actions, provide solutions, and improvements using root cause analysis tools to resolve issues
  • Lead and complete CAPA investigations as required
  • Perform effectiveness verification on CAPA and nonconformances
  • Monitor nonconformances, CAPAs, GAPs, and QPs to ensure timely completion
  • Participate in external/internal Quality System audits including managing the backroom.
  • Effectively drive on time closure of Quality System audit findings
  • Lead internal audits and support Recovery Partner audits which includes assisting Management with developing the yearly audit schedule
  • Coordinate and help management develop department training as relates to the area
  • Provide support to management with training of QSEs
  • Undertake continuous training and development, including lead auditor training
  • Backup trainer for QSR on-boarding training to corporate new hires
  • Manage oversight of the corporate change control process and ensure timely completion
  • Effectively report data to management on Key Performance Indicators (KPIs)
  • Contribute to continuous improvement activities including the development of eQMS modules
  • Execute necessary validations assigned to Quality Systems for the eQMS software
  • Conduct gap analyses to new or revised Quality System standards and regulations
  • Assist with the development, maintenance, and support for the eQMS software system
  • Assist with QMS management review
  • Key member for any Quality System impacting projects including collaborating with other sites
  • Complete other functions as they may be assigned
Qualifications:
  • Bachelor's degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years' work experience.
  • 5+ years of experience in quality engineering, quality assurance/systems, or a similar role.
  • Professional certification: ASQ CQA/CQE/LSS and/or AATB CTBS certification
  • Experience with electronic quality management systems and using QA software tools.
  • Strong analytical and problem-solving skills
  • Excellent verbal and written communication skills, including business writing.
  • Working knowledge of current Good Manufacturing Practices, Good Tissue Practices, Tissue Banking Regulations, Quality System Regulations, and ISO Standards.


This is a hybrid position, based out of our corporate headquarters in Kennesaw, GA. Relocation assistance will not be provided.

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