Head of Design Quality

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October 23

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DX

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SaaS • B2B • Artificial Intelligence

DX is a developer intelligence platform that helps engineering leaders measure developer productivity, track AI-assisted tooling adoption, and optimize software delivery. The product combines analytics, benchmarking, and an AI copilot to deliver insights, detect risks, and accelerate engineering velocity via tooling like software catalogs, Backstage plugins, scorecards, and workflow automation.

51 - 200 employees

☁️ SaaS

🤝 B2B

🤖 Artificial Intelligence

📋 Description

• Perform the role of the Quality representative in Design and Development Projects. • Responsible for Risk Management file creation and maintenance for products. • Provide Quality Assurance support to assay and software verification and validation activities. • Perform the review and approval of Assay Verification and Validation Protocols and Reports. • Performs the review and approval of Software Verification and Validation Protocols and Reports. • Performs review of Design Changes to identify the impact to products developed under design controls. • Performs risk assessments for Design Changes. • Ensure project plans adequately address design, verification, validation and compliance requirements and standards. • Work with functional departments to ensure tasks are executed compliantly. Ensure resolution of protocol variances are performed ensuring compliance and issues are addressed and resolved. • Management and documentation of Design Control activities • Management and maintenance of the product Risk Management File according to ISO 14971:2019 • Support Quality System development and improvement to comply to ISO 13485 and FDA 21CFR820 and other applicable regulations. • Support post launch design changes and product updates as required. • Provides Quality Assurance expertise, guidance, coaching for New Product Development and single site PMA PAI Inspections. • Follow all functions and responsibilities associated to this position that are described in UDx documents.

🎯 Requirements

• Bachelor’s degree in Life sciences, OR a related field is preferred. • 15+ years of experience in a Quality Management role in the Medical Device, OR an equivalent combination of education, training, and/or experience. • More than 4 years of IVD experience working with FDA approved class III IVD products, OR an equivalent combination of education, training, and/or experience. • Single site PMA experience required. • Expert in the interpretation of 21CFR820, IVD single site PMA projects including the review of Assay and Software documentation. • Working knowledge interpreting and implementing 21CFR820, ISO 13485, ISO 14971, ISO 62304 and CLIA Regulations 42 CFR 493.

🏖️ Benefits

• 22 days of PTO with the possibility to carry over 10 days to the following year. • Company Holidays, plus your Birthday off! • Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k). • Flexible work schedule • Relocation support to the DFW area for on-site roles. • And more to come