Quality Engineer I - Medical Devices | NPD & CAPA

Artivion, Inc.; Austin (TX); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401(k) with traditional and Roth

Employee Stock Purchase Plan (ESPP)

Paid Holidays

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin is seeking a Quality Engineer I to provide functional QE support for new product development and ongoing product line assurance.

You will ensure compliance with federal and industry regulations during receipt, storage, manufacture, and distribution of our medical devices. The role emphasizes collaborating with R&D and manufacturing teams, handling non-conformances, validations, and CAPAs to help ensure product reliability and patient safety, with opportunities for

Qualifications

• Bachelor’s Degree in engineering field or equivalent experience.
• 0–2 years experience in FDA-regulated medical device environments.
• Strong knowledge of GMP, QSR, and ISO standards.
• Experience with quality engineering processes in NPD and transfer to manufacturing.

Responsibilities

• Provide Quality Engineering project support for NPD and transfer to manufacturing.
• Provide Quality Engineering technical support to assist in resolving quality issues.
• Analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.
• Prepare, execute, and analyze validations to approve equipment, processes, and software used in testing, processing, storing, and distribution of products.
• Collect, statistically analyze, and develop report packages to support validations and engineering studies.
• Assist in the development, implementation, and documentation of qualifications/validations to ensure products are reliable, safe, and effective prior to release.
• QE duties include: partner with R&D and cross-functional groups to support development and launch; apply design controls and risk management; sampling plans and CAPA investigations.

Skills

Quality Engineering

Statistical analysis

CAPA management

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

Validation protocols

Risk management (FMEA)

Job description

Artivion, Inc. in Austin is seeking a Quality Engineer I to provide functional QE support for new product development and ongoing product line assurance.

You will ensure compliance with federal and industry regulations during receipt, storage, manufacture, and distribution of our medical devices. The role emphasizes collaborating with R&D and manufacturing teams, handling non-conformances, validations, and CAPAs to help ensure product reliability and patient safety, with opportunities for