Quality Engineer I – Medical Devices, NPD & CAPA Focus

On-X Life Technologies, Inc.; Austin (TX); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life Insurance

401(k) plan

ESPP

10 paid holidays

Competitive PTO

Tuition reimbursement

Job summary

Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to support new product development and existing product lines with Quality Engineering and Quality Assurance techniques.

You will analyze non-conformances, lead CAPA activities, validate equipment, processes, and software, and collaborate with R&D and manufacturing to ensure products are reliable, safe, and compliant prior to release.

Qualifications

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

Responsibilities

• Provide Quality Engineering 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 proven reliable, safe, and effective prior to release.
• QE duties include: Partner with R&D and cross-functional groups to support development and commercial launch; apply design controls, risk management, and investigation/correction of design failures; sampling plans and acceptance sampling for manufacturing data; develop Risk Management Documents including FMEA's; review and validate Test Methods; interface with manufacturing facilities; conduct investigations, CAPAs and customer complaints.

Education

Bachelor's degree in engineering field

Job description

Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to support new product development and existing product lines with Quality Engineering and Quality Assurance techniques.

You will analyze non-conformances, lead CAPA activities, validate equipment, processes, and software, and collaborate with R&D and manufacturing to ensure products are reliable, safe, and compliant prior to release.