Quality Systems Engineer
Austin, TX · On-site
Own subsets of the Quality System related to software design controls, including but not limited to: * Software Design Control processes * Software Risk Management * Software Change Control
Austin, TX · On-site
Own subsets of the Quality System related to software design controls, including but not limited to: * Software Design Control processes * Software Risk Management * Software Change Control
Austin, TX · On-site
Own subsets of the Quality System related to software design controls, including but not limited to: * Software Design Control processes * Software Risk Management * Software Change Control
Austin, TX · Hybrid
Medical
Dental
Vision
Life
Retirement
PTO
Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both ...
Austin, TX · Hybrid
Medical
Dental
Vision
Life
Retirement
PTO
Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both ...
Austin, TX · Hybrid
Medical
Dental
Vision
Life
Retirement
PTO
Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both ...
Austin, TX · Hybrid
Medical
Dental
Vision
Life
Retirement
PTO
Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both ...
Austin, TX · On-site
$71K - $119K/yr
Medical
Dental
Vision
Retirement
Own subsets of the Quality System related to software design controls, including but not limited to: * Software Design Control processes * Software Risk Management * Software Change Control
Austin, TX · On-site
$71K - $119K/yr
Medical
Dental
Vision
Retirement
Own subsets of the Quality System related to software design controls, including but not limited to: * Software Design Control processes * Software Risk Management * Software Change Control
Round Rock, TX · On-site
$67K - $86K/yr
Overview Reporting to the Senior Director of Quality, the Quality Engineer is responsible for driving quality system improvements through data analysis, risk assessment, validation support, and root ...
Quick apply
Round Rock, TX · On-site
$67K - $86K/yr
Overview Reporting to the Senior Director of Quality, the Quality Engineer is responsible for driving quality system improvements through data analysis, risk assessment, validation support, and root ...
Round Rock, TX · On-site
$67K - $86K/yr
Overview Reporting to the Senior Director of Quality, the Quality Engineer is responsible for driving quality system improvements through data analysis, risk assessment, validation support, and root ...
Round Rock, TX · On-site
$67K - $86K/yr
Overview Reporting to the Senior Director of Quality, the Quality Engineer is responsible for driving quality system improvements through data analysis, risk assessment, validation support, and root ...
The position is responsible for managing quality system processes including deviations, non-conformance reports (NCRs), CAPA, and change control, ensuring issues are appropriately investigated ...
The position is responsible for managing quality system processes including deviations, non-conformance reports (NCRs), CAPA, and change control, ensuring issues are appropriately investigated ...
The position is responsible for managing quality system processes including deviations, non-conformance reports (NCRs), CAPA, and change control, ensuring issues are appropriately investigated ...
Quick apply
The position is responsible for managing quality system processes including deviations, non-conformance reports (NCRs), CAPA, and change control, ensuring issues are appropriately investigated ...
This role supports implementation and execution of Quality System processes through team leadership, workflow coordination, training oversight, and operational compliance activities. The QA ...
Quick apply
This role supports implementation and execution of Quality System processes through team leadership, workflow coordination, training oversight, and operational compliance activities. The QA ...
Austin, TX · Hybrid
$71K - $92K/yr
Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The Quality Engineer works with QE Manager/QA Director ...
Austin, TX · Hybrid
$71K - $92K/yr
Quality Engineer supports the quality system processes of the Natera CLIA laboratories and activities associated with CE-IVD kits and software. The Quality Engineer works with QE Manager/QA Director ...
This role supports implementation and execution of Quality System processes through team leadership, workflow coordination, training oversight, and operational compliance activities. The QA ...
This role supports implementation and execution of Quality System processes through team leadership, workflow coordination, training oversight, and operational compliance activities. The QA ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics. * Continuously expand product, system, and technology knowledge to support evolving ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics. * Continuously expand product, system, and technology knowledge to support evolving ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics. * Continuously expand product, system, and technology knowledge to support evolving ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics. * Continuously expand product, system, and technology knowledge to support evolving ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics. * Continuously expand product, system, and technology knowledge to support evolving ...
Austin, TX · On-site
Medical
Dental
Vision
Life
Retirement
PTO
Track project validation progress and ensure proper documentation of test coverage, results, and quality metrics. * Continuously expand product, system, and technology knowledge to support evolving ...
Manor, TX · On-site
$26 - $33/hr
Supporting calibration activities and quality system requirements. * Assisting with training and mentoring less experienced inspectors as needed. * Promoting and enforcing company quality and safety ...
Quick apply
Manor, TX · On-site
$26 - $33/hr
Supporting calibration activities and quality system requirements. * Assisting with training and mentoring less experienced inspectors as needed. * Promoting and enforcing company quality and safety ...
Austin, TX · On-site
Conduct internal audits of the quality system and other business functions * Evaluating nonconforming material and dispositioning based on cross-functional engineering review * Assuring compliance to ...
Austin, TX · On-site
Conduct internal audits of the quality system and other business functions * Evaluating nonconforming material and dispositioning based on cross-functional engineering review * Assuring compliance to ...
Austin, TX · On-site
Conduct internal audits of the quality system and other business functions * Evaluating nonconforming material and dispositioning based on cross-functional engineering review * Assuring compliance to ...
Austin, TX · On-site
Conduct internal audits of the quality system and other business functions * Evaluating nonconforming material and dispositioning based on cross-functional engineering review * Assuring compliance to ...
Austin, TX · On-site
$129K - $258K/yr
Medical
Life
Retirement
This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for ...
Austin, TX · On-site
$129K - $258K/yr
Medical
Life
Retirement
This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for ...
Austin, TX · On-site
$129K - $258K/yr
Medical
Life
Retirement
This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for ...
Austin, TX · On-site
$129K - $258K/yr
Medical
Life
Retirement
This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for ...
$13.82 - $15.62
7% of jobs
$15.62 - $17.42
2% of jobs
$17.42 - $19.21
3% of jobs
$19.21 - $21.01
10% of jobs
$22.51 is the 25th percentile. Wages below this are outliers.
$21.01 - $22.81
3% of jobs
$22.81 - $24.61
14% of jobs
$24.61 - $26.40
10% of jobs
The median wage is $26.49 / hr.
$26.40 - $28.20
22% of jobs
$28.52 is the 75th percentile. Wages above this are outliers.
$28.20 - $30
21% of jobs
$30 - $31.80
4% of jobs
$31.80 - $33.60
3% of jobs
$13
$25
$33
| Aspect | Quality System | Quality Assurance |
|---|---|---|
| Definition | Framework of policies, processes, and procedures to ensure quality management across an organization. | Part of the quality system focused on preventing defects through planned activities and systematic processes. |
| Focus | Overall quality management and compliance | Preventing defects and ensuring product/service quality |
| Certifications | ISO 9001, QS-9000 | ISO 9001, Six Sigma, CQA |
| Work Environment | Cross-departmental, organizational-wide | Specific to quality processes and audits |
In summary, a Quality System encompasses the entire framework for managing quality within an organization, including policies and procedures. Quality Assurance is a key component of the Quality System, focusing specifically on preventing defects and ensuring quality through systematic activities.

Team Description:
Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.
We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.
Job Description and Responsibilities:
As a Quality Systems Engineer (dedicated towards Design Controls), your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.
You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.
You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:
Required Qualifications:
Preferred Qualifications:
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Biotechnology research and development
201 - 500 Employees
San Francisco, CA, US
2016