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Senior Manager Quality Engineering

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Talently

San Diego, CA (In Person)

$147,500 Salary, Full-Time

Posted 4 days ago (Updated 2 days ago) • Actively hiring

Expires 6/29/2026

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Job Description

Senior Manager Quality Engineering at Talently Senior Manager Quality Engineering at Talently in San Diego, California Posted in about 3 hours ago.
Type:
full-time
Job Description:
Job Title:
Senior Manager Quality Engineering Location:
On Site -
San Diego, California, United States Salary:
$120,000-$175,000
Skills:
ISO 13485, IVD
Quality Engineering, FDA 21 CFR Part 820, Design Controls, CAPA About the Biotechnology Research Company /
The Opportunity:
Step into a pivotal role with a leading innovator in Biotechnology Research, where groundbreaking diagnostic solutions are developed to transform patient outcomes. This opportunity places you at the heart of a company dedicated to maintaining world-class quality standards across the product lifecycle of in-vitro diagnostic (IVD) technologies. As a Senior Manager in Quality Engineering, you will help ensure regulatory compliance and support a collaborative, fast-paced environment where the impact of your work is tangible and far-reaching.
Responsibilities:
Support and maintain an ISO 13485 and 21 CFR Part 820-compliant Quality Management System (QMS). Participate in design control activities, including risk management and design verification/validation for IVD products. Lead and drive corrective and preventive action (CAPA), deviations, and nonconformance investigations. Assist and prepare for internal and external audits, including FDA inspections and notified body audits. Collaborate closely with R D, Regulatory, and Manufacturing to ensure quality and compliance across product development. Manage and support documentation activities such as SOPs, work instructions, and technical files. Contribute to continuous improvement initiatives within quality systems and operational processes.
Must-Have Skills:
Bachelor's degree in Engineering, Life Sciences, or a related field. 3-7 years of experience in quality roles within medical device or diagnostics, ideally with direct IVD experience. In-depth knowledge of ISO 13485 and FDA quality regulations (21 CFR Part 820). Hands-on experience supporting design controls, risk management, and validation activities. Excellent attention to detail and strong cross-functional communication skills.
Nice-to-Have Skills:
Experience with regulatory submissions such as FDA 510(k) processes. Background in supporting both internal and external audit activities. Familiarity with supporting continuous improvement and change management within quality systems. Prior experience in a fast-paced, growth-oriented diagnostic or biotechnology environment. Strong collaborative mindset for working with multi-disciplinary teams throughout the product lifecycle.