Quality Engineer I - Medical Devices NPD & CAPA

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

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401(k) with matching

Employee Stock Purchase Plan (ESPP)

Paid Holidays

Competitive PTO

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to join our On-X Heart Valve team. You will apply quality engineering methods to support new product development and ensure compliance with federal, industry, and corporate standards.

The ideal candidate has a bachelor’s degree in engineering and 0–2 years of experience, with strong analytical skills to drive CAPA, validations, risk management, and supplier/manufacturing interfaces.

Qualifications

• Bachelor’s Degree in engineering field or equivalent experience.
• 0–2 years experience in FDA-regulated environments with knowledge of GMP, QSR, ISO standards.

Responsibilities

• Provide QE project support for NPD and transfer to manufacturing.
• Provide QE technical support to resolve quality issues.
• Analyze non-conformances and implement CAPA plans.
• Prepare, execute, and analyze validations for equipment, processes, and software.
• Collect and analyze data to support validations and studies.
• Develop qualifications/ validations ensuring products are reliable, safe and effective.
• Partner with R&D and cross-functional groups to support development and launches.

Skills

Quality Engineering

Education

Bachelor's Degree in Engineering

Job description

Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to join our On-X Heart Valve team. You will apply quality engineering methods to support new product development and ensure compliance with federal, industry, and corporate standards.

The ideal candidate has a bachelor’s degree in engineering and 0–2 years of experience, with strong analytical skills to drive CAPA, validations, risk management, and supplier/manufacturing interfaces.