Real Staffing
Quality Engineer- Class III Implantible Devices- Austin TX
Real Staffing, Austin, Texas, us, 78716
Quality Engineer - Class III Implantable Devices
Join Our Client's Team in Delivering Life-Changing Solutions!
Our client is seeking a dedicated Medical Device Quality Engineer to join their innovative team in Austin, Texas. 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. In this role, you'll play a pivotal part in ensuring compliance with U.S. and international regulations while working alongside a team committed to medical innovation. Ongoing training and mentoring are provided to support your growth. Key Responsibilities:
Maintain the Quality Management System (QMS) in compliance with 21 CFR Parts 803, 806, and 820, ISO 13485:2016, and ISO 14971:2019 standards. 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. If you're driven by precision, quality, and the opportunity to make a meaningful difference in healthcare, we encourage you to apply today. Help our client continue their mission of innovating 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 factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com
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Join Our Client's Team in Delivering Life-Changing Solutions!
Our client is seeking a dedicated Medical Device Quality Engineer to join their innovative team in Austin, Texas. 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. In this role, you'll play a pivotal part in ensuring compliance with U.S. and international regulations while working alongside a team committed to medical innovation. Ongoing training and mentoring are provided to support your growth. Key Responsibilities:
Maintain the Quality Management System (QMS) in compliance with 21 CFR Parts 803, 806, and 820, ISO 13485:2016, and ISO 14971:2019 standards. 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. If you're driven by precision, quality, and the opportunity to make a meaningful difference in healthcare, we encourage you to apply today. Help our client continue their mission of innovating 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 factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com
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