Quality Systems Engineer I (Hybrid)

On-X Life Technologies, Inc.; Austin (TX); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and 401

Life Insurance

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin is seeking a Quality Engineer to oversee the Quality Management System (QMS) and ensure compliance with required regulations. You will assist in managing audits, corrective action programs, and quality planning.

The ideal candidate has a Bachelor's degree in a technical field and at least 1 year of experience in quality engineering. Benefits include comprehensive medical coverage, a 401(k) plan, and tuition reimbursement.

Qualifications

• 1+ years of experience in quality engineering or similar role.
• ASQ CQA/CQE/LSS certification preferred.
• Strong understanding of Good Manufacturing Practices and Quality System Regulations.

Responsibilities

• Oversee implementation and maintenance of the QMS.
• Support corporate quality objectives within budget.
• Participate in Quality System audits.

Skills

Quality engineering

Quality assurance

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's degree in a technical/scientific field

Tools

Electronic quality management systems

QA software tools

Job description

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 at 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. Help senior QSEs manage external audit assessments/internal audit program. Assist with assuring the Corrective and Preventive Action Program (CAPA) and Audit Program requirements comply with all applicable requirements and keep management advised of the status of these programs. To assist with 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 quality objectives and 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 ensure timely completion.
• 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 the eQMS.
• Provide support and monitor the 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 our eQMS.
• 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.

Benefits

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 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.