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Quality Engineer – Class III Implantable Devices – Austin, TX
This permanent role involves supporting and maintaining the company's Quality Management System (QMS) while actively contributing to the design and development of groundbreaking spinal system devices. You will ensure compliance with U.S. and international regulations and work with a team committed to medical innovation.
Base pay range $120,000.00/yr
Key Responsibilities
Maintain the QMS in compliance with 21 CFR Part 803, 806, 820, ISO 13485:2016, and ISO 14971:2019.
Monitor QMS health and metrics, and provide data for management reviews.
Lead CAPA investigations and Medical Device Reporting activities.
Oversee document control processes and perform complaint investigations.
Support new product development through design control deliverables and sustaining engineering projects.
Required Expertise
Strong knowledge of 21 CFR Part 820, ISO 14971:2019, and ISO 13485:2016.
Experience in the medical device industry, with proficiency in Quality Systems management and regulatory standards.
Proficiency in CAPA, document control, and design control.
If you're driven by precision and quality, we encourage you to apply today and help innovate life‑changing spinal systems.
EOE Statement:
Specialist Staffing Group is 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, or veteran status.
In addition to base pay, direct‑hire employees may be eligible for client‑offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on location and hire date and is subject to change.
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Base pay range $120,000.00/yr
Key Responsibilities
Maintain the QMS in compliance with 21 CFR Part 803, 806, 820, ISO 13485:2016, and ISO 14971:2019.
Monitor QMS health and metrics, and provide data for management reviews.
Lead CAPA investigations and Medical Device Reporting activities.
Oversee document control processes and perform complaint investigations.
Support new product development through design control deliverables and sustaining engineering projects.
Required Expertise
Strong knowledge of 21 CFR Part 820, ISO 14971:2019, and ISO 13485:2016.
Experience in the medical device industry, with proficiency in Quality Systems management and regulatory standards.
Proficiency in CAPA, document control, and design control.
If you're driven by precision and quality, we encourage you to apply today and help innovate life‑changing spinal systems.
EOE Statement:
Specialist Staffing Group is 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, or veteran status.
In addition to base pay, direct‑hire employees may be eligible for client‑offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on location and hire date and is subject to change.
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