Associate Director​/Director of Quality

Company Description

Mindera Health™ develops scalable extraction technology and advanced data analysis to provide individual transcriptomic insights for patients. Its Dermal Intelligence™ platform delivers actionable information to payers, providers, and patients to inform more effective and efficient treatment decisions. The flagship test, Mind.

Px, combines a dermal biomarker patch with Machine Learning to predict a patient’s likely response to costly psoriasis biologic therapies, helping payers avoid unnecessary spending. Mind.

Px is the first in a planned pipeline of tests targeting biologic receptivity for conditions such as psoriatic arthritis and eczema. Mindera Health is focused on transforming dermatologic care through precision diagnostics that support better outcomes and more personalized treatment strategies.

The Associate Director/Director of Quality is a full-time, on-site role based in Vista, CA. This role oversees the design, implementation, and continuous improvement of the company’s Quality Management System to support diagnostic product development, manufacturing, and commercialization. Day-to-day responsibilities include leading quality assurance and quality control activities, supervising quality audits, managing documentation and change control, and ensuring adherence to applicable regulatory and industry standards.

The person in this role collaborates closely with operations, R&D, regulatory, and commercial teams to resolve quality issues, support process validation, and drive risk mitigation initiatives. The Associate Director/Director of Quality also develops quality metrics, trains team members on quality practices, and prepares the organization for internal and external inspections.

• Strong foundation in Quality Assurance and Quality Control, including developing, implementing, and maintaining quality procedures and work instructions.
• Experience with Quality Management systems and frameworks, including governance of documentation, corrective and preventive actions (CAPA), and continuous improvement initiatives.
• Demonstrated competence in Quality Auditing, including planning, executing, and following up on internal and supplier audits.
• Advanced Analytical Skills to review data, identify trends, assess risk, and support evidence-based decisions related to product and process quality.
• Experience in regulated healthcare, diagnostics, medical device, or biotechnology environments, with working knowledge of relevant standards and regulations (e.g., FDA, CLIA, ISO).
• Proven ability to lead cross-functional teams, communicate clearly, and influence stakeholders at multiple levels of the organization.
• Bachelor’s degree in a scientific, engineering, or related discipline; advanced degree or professional quality certification (e.g., ASQ, ISO lead auditor) is preferred.
• Comfort working on-site in a fast-paced, growth-oriented environment and managing multiple priorities with attention to detail.

$160,000-$180,000 base salary plus performance bonus and stock options