Onsite Quality Engineer – Medical Devices, NPD & Validation

Artivion, Inc.; Austin (TX); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

5 weeks PTO and 10 holidays

Health, dental, vision insurance

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

EAP and legal benefits

Job summary

Artivion, Inc. Austin facility specializes in On-X Mechanical Heart Valves. The Quality Engineering role focuses on applying QA techniques to new product development and ongoing product support, ensuring compliance with GMP, QSR, and ISO standards during receipt, storage, and distribution of materials.

The ideal candidate will lead validation efforts, perform risk assessments, and drive CAPA programs across cross-functional teams to ensure safe, effective medical devices reach the market.

Qualifications

• Bachelor's degree in Engineering or science field or equivalent work experience.
• 4+ years hands-on quality engineering in FDA-regulated environments (medical device/pharma).
• Knowledge of GMP, QSR, ISO standards; statistical methods and acceptance sampling.

Responsibilities

• Provide QE leadership for NPD and transfer to manufacturing.
• Drive quality issue resolution and CAPA for products and processes.
• Create/approve validation protocols and DHF documents.
• Lead risk management and FMEA documentation.
• Coordinate validation activities across facilities and projects.
• Interface with manufacturing sites to ensure quality compliance.

Skills

Quality Systems

Statistical Methods

Acceptance Sampling

Design Controls

Risk Management

FMEA

Verifications & Validations

CAPA investigations

Education

Bachelor's degree in Engineering or science

Job description

Artivion, Inc. Austin facility specializes in On-X Mechanical Heart Valves. The Quality Engineering role focuses on applying QA techniques to new product development and ongoing product support, ensuring compliance with GMP, QSR, and ISO standards during receipt, storage, and distribution of materials.

The ideal candidate will lead validation efforts, perform risk assessments, and drive CAPA programs across cross-functional teams to ensure safe, effective medical devices reach the market.