Senior QA Specialist - Biotech/IVD Quality & Compliance

DCN Diagnostics; Carlsbad (CA); On-site; USD 102,000 - 115,000; Full time

Job summary

DCN Diagnostics is seeking a Senior QA Specialist to support quality systems and compliance for IVD/biomedical devices. You will manage eQMS, lead CAPA investigations, and contribute to risk management and design verification across products, working independently within established procedures.

The role emphasizes quality system ownership and cross‑functional collaboration within a fast‑paced biotech setting.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Minimum of 5 years of QA experience in biotech/IVD/medical device.
• Experience applying ISO 13485:2016 and FDA QMSR (21 CFR Part 820).
• Hands-on experience administering and maintaining eQMS software and training records; 21 CFR Part 11 knowledge.
• Familiarity with EU IVDR and FDA regulatory submissions, audits, and readiness.

Responsibilities

• Manage QMS administration and process improvements.
• Lead and coordinate CAPA investigations and corrective actions.
• Support audits and inspection readiness activities.
• Coordinate technical documentation and design records with owners.
• Support risk management, verification/validation activities, and continuous improvement.
• Mentor colleagues and coordinate cross‑functional quality projects.

Skills

QMS Administration

Documentation management

CAPA processes

Risk management

Audit readiness

Regulatory compliance

Education

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

Advanced degree preferred

ISO 13485 Lead Auditor training

ASQ Certification (QA Auditor/Engineer)

Tools

eQMS software

Job description

DCN Diagnostics is seeking a Senior QA Specialist to support quality systems and compliance for IVD/biomedical devices. You will manage eQMS, lead CAPA investigations, and contribute to risk management and design verification across products, working independently within established procedures.

The role emphasizes quality system ownership and cross‑functional collaboration within a fast‑paced biotech setting.