Senior Quality Engineer
Job in
Austin, Travis County, Texas, 78716, USA
Listed on 2026-10-02
Listing for:
Meet Life Sciences Ltd.
Full Time
position Listed on 2026-10-02
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Senior Quality Engineer | Medical Device
Location: Remote, US Based
Employment Type: Contract
Industry: Medical Device
About the OpportunityWe are partnering with a growing medical device company that is looking to add a Senior Quality Engineer to their team. This is a hands-on opportunity within a small organization where the individual will have meaningful ownership across quality systems, product development, and manufacturing.
The ideal candidate will have small/start-up experience in the medical device industry.
Responsibilities- Support and maintain the Quality Management System in accordance with ISO 13485, FDA requirements, and 21 CFR Part 820/QMSR
. - Support Design Controls, risk management, verification and validation, and design changes
. - Lead and support CAPA, nonconformances, deviations, and root cause investigations
. - Support internal, supplier, and external quality audits
. - Partner with Engineering, Manufacturing, and Regulatory teams to resolve quality issues and improve processes.
- Support supplier quality activities and manufacturing quality initiatives.
- Develop and maintain quality procedures, work instructions, and controlled documentation.
- Monitor quality data and identify opportunities for continuous improvement.
- Bachelor's degree in Engineering, Quality, or a related technical field.
- 5+ years of medical device quality engineering experience
. - Strong knowledge of ISO 13485 and FDA Quality System requirements
. - Experience with CAPA, nonconformances, root cause analysis, and audits
. - Experience with Design Controls, risk management, and V&V.
- Familiarity with ISO 14971
. - Strong communication, documentation, and problem-solving skills.
- Comfortable working independently in a small or growing medical device environment
.
Position Requirements
10+ Years
work experience
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