Senior Quality Engineer – Med Device NPD & Validation

CryoLife, Inc.; Austin, Northern (TX, KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

5 weeks PTO

Holiday provision

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Employee Assistance Program

Wellness programs

Onsite benefits

Job summary

Artivion, Inc. is seeking a Quality Engineer to provide leadership across NPD transfers to manufacturing and ongoing product support.

You will drive quality improvements, validate processes, and ensure compliance with GMP, QSR, and ISO standards while partnering with cross-functional teams to enable successful product launches. The role requires 4+ years in a regulated medical device or similar industry, strong statistical and validation skills, and the ability to navigate complex quality

Qualifications

• Bachelor's degree in Engineering or science, or equivalent work experience.
• 4+ years hands-on experience in FDA/regulatory industry with GMP, QSR, and ISO knowledge.
• Strong knowledge of statistical methods and acceptance sampling in regulated industries.
• Experience designing, executing, and analyzing validations and supporting documentation.
• Ability to implement Artivion Quality Systems and interface with regulatory bodies; ASQ certs preferred but not required.

Responsibilities

• Provide Quality Engineering leadership for NPD and transfer to manufacturing.
• Lead technical efforts to resolve quality issues and ensure compliant product releases.
• Create, review and approve Protocols, Process and Product Validations.
• Develop and approve Design History File documentation.
• Conduct internal or supplier quality system audits as assigned.
• Develop validation strategies and plans aligned with corporate projects.

Skills

Quality Engineering

Statistical methods

CAPA

Regulatory knowledge

Design controls

Risk management

Education

Bachelor's degree in Engineering or science field

ASQ CQE/CQA certification preferred

Job description

Artivion, Inc. is seeking a Quality Engineer to provide leadership across NPD transfers to manufacturing and ongoing product support.

You will drive quality improvements, validate processes, and ensure compliance with GMP, QSR, and ISO standards while partnering with cross-functional teams to enable successful product launches. The role requires 4+ years in a regulated medical device or similar industry, strong statistical and validation skills, and the ability to navigate complex quality