Quality Systems Engineer I (Hybrid

Locations

Showing 1 location
Austin
1300 East Anderson Lane
Bldg. A
Austin, TX , USA

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• Hybrid
• Lab Operations
• Full-Time
• Requisition #: QUALI
  002496

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website

Position Objective
:

Responsible foroperatingthe Quality Management System (QMS). Toassistin providingassurancethe Companyoperatesin compliance with all required regulations and standards asdeterminedby both internal and external assessments.

Help senior QSEs manage external audit assessments/internal auditprogram.

Assist with assuring the Corrective and Preventive Action Program (CAPA) and Audit Program requirements comply withall applicable requirements and keep management advised of the status of these programs.

Toassistwith management review, nonconformance oversight, quality planning, and change control.

Responsibilities:

• Oversee effective implementation and maintenance of the Quality Management System throughout the company.
• Support corporate qualityobjectivesand achieve those goals within budget.
• Maintain Quality Procedures and ensure contents are appropriate for business; revise as needed.
• Provide support on solutions for corrective and preventive actions and improvements using root cause analysis tools to resolve issues.
• Perform effectiveness verification on CAPA and nonconformances.
• Monitor nonconformances and CAPAs to ensuretimelycompletion.
• Participate in external/internal Quality System audits including supporting the backroom.
• Effectively drive on time closure of Quality System audit findings
• Perform the closure review of Internal Audit packets.
• Undertake continuous training and development including learning theeQMS.
• Provide support andmonitorthe corporate change control process.
• Support running reports and pulling data as needed for Key Performance Indicators (KPIs)
• Contribute to continuous improvement activities including improvements to oureQMS.
• Monitor the completion of gap analyses to new/revised standards and regulations.
• Monitor the completion of Quality Plans for on time activities and closure.

Other responsibilities as assigned.

Qualifications
:

• Bachelor’s degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years’ work experience.
• 1+ years of experience in quality engineering, quality assurance, or a similar role.
• ASQ CQA/CQE/LSS certification preferred.
• Experience with electronic quality management systems and using QA software tools is preferred.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Working knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
• Comprehensive Medical, Dental, and Vision
• Life Insurance
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement

Equal Employment Opportunity Employer (EEO):

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.

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