Senior QA Specialist Biotech/IVD Compliance

DCN Dx, Inc.; Carlsbad (CA); Sur place; USD 102 000 - 115 000; Plein temps

Résumé du poste

DCN Dx, Inc. seeks a Senior QA Specialist to lead quality assurance for biotech and IVD products. The role administers eQMS, coordinates design documentation, and drives CAPA and risk management activities. It requires hands-on quality expertise and capability to mentor colleagues without supervision.

Critical tasks include supporting audits, training on quality systems, and ensuring regulatory compliance (ISO 13485, FDA QMSR). The position is onsite in Carlsbad, CA, with full-time hours.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (required).
• Advanced degree preferred but not required for all candidates.

Responsabilités

• Administers and improves the electronic quality management system (eQMS).
• Leads quality investigations and CAPA and supports audit readiness.
• Coordinates technical documentation and design records with owners.
• Develops documentation and eQMS training materials.
• Supports risk management, verification/validation, and continuous improvement.
• Escalates significant quality risks to QA leadership while mentoring colleagues.

Connaissances

QMS Administration

Design & Development Quality

CAPA & Investigations

Audit readiness

Risk management

Documentation training

Formation

Bachelor’s degree in Life Sciences, Engineering, or related field

Advanced degree preferred

Outils

eQMS software

Description du poste

DCN Dx, Inc. seeks a Senior QA Specialist to lead quality assurance for biotech and IVD products. The role administers eQMS, coordinates design documentation, and drives CAPA and risk management activities. It requires hands-on quality expertise and capability to mentor colleagues without supervision.

Critical tasks include supporting audits, training on quality systems, and ensuring regulatory compliance (ISO 13485, FDA QMSR). The position is onsite in Carlsbad, CA, with full-time hours.