New · posted Oct 15
Artivion · Medical Devices
Quality Engineer I
- Austin, TX
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Position Objective
The Quality Engineer I utilizes Quality Engineering and Quality Assurance techniques to provide functional support for new product development and product line support. This position also ensures that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
What you need
- Minimum of a Bachelor’s Degree in engineering field or equivalent experience.
- 0-2 years experience; preferably in a FDA regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
What you'll do
- 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 the 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 that the products processed are proven to be reliable, safe, and effective prior to release.
- QE duties include:
- Partner with R&D and other cross functional groups to support successful development and commercial launch of new products.
- Partner with R&D and other cross functional groups to support the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
- Accountability for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. including assessing, applying and interpreting acceptance sampling for manufacturing data.
- Assist in Development of Risk Management Documents to include FMEA’s.
- Review, approve, and validate Test Methods.
- Interface with manufacturing facilities as required.
- Conduct investigations, bounding, documentation, and review of non-conformances, CAPA’s and customer complaints as necessary.
Other responsibilities as assigned.
Pay and benefits
Artivion didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Comprehensive Medical, Dental, and Vision
Life Insurance
Supplemental Benefits
401(k) with both Traditional and Roth options available
Employee Stock Purchase Plan (ESPP)
10 Paid Company Holidays
Competitive PTO plan
Tuition Reimbursement
Where you'll work
Austin, TXOn-siteOpen in Maps (opens in a new tab)
More jobs in Austin, TXFrom the posting
About Artivion
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.
Equal opportunity, accessibility and legal noticesArtivion's statements, word for word
Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in Texas5 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Texas (middle half) | $73,000 | $73,000 | $78,500 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Artivion's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 11 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs4
- Validation and qualification4
- GMP and compliance2
- Lab testing and methods2
- Investigations and CAPA2
- Quality systems and risk2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Artivion on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Regulatory2 50%
- Quality2 50%
By level
- Director1 25%
- Manager1 25%
- Senior & Principal1 25%
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Quality Engineer I at Artivion
Open until filled.