Senior QA Specialist

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

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Senior QA Specialist

1.1 Operations Full Time Professional Carlsbad, CA, US

9 days ago Requisition ID: 1015

Salary Range: $102,000.00 To $115,000.00 Annually

Summary

The Senior Quality Assurance Specialist is a senior individual contributor supporting quality and compliance for the organization’s biotech and in vitro diagnostic (IVD) products, with a primary focus on IVD/medical-device quality systems and design assurance. Working independently within established procedures and delegated authority, the Specialist administers and improves the electronic quality management system (eQMS), leads assigned quality investigations and corrective and preventive actions (CAPA), and supports audit and inspection readiness. The role coordinates technical documentation and design and development records with technical owners , develops documentation and eQMS training, and supports risk management, verification and validation, and continuous improvement. The Specialist escalates significant quality risks to the Director, Quality Assurance and Quality Systems and mentors colleagues without direct supervisory responsibility.

Essential Functions

• Quality Management System (QMS) Administration (approximately 15% of time)
• Technical File Management (approximately 20% of time)
• Training and Documentation (approximately 10% of time)
• Process Improvement (approximately 30% of time)
• Design and Development Quality Support (approximately 10% of time)
• Production, Supplier, and Post-Market Quality Support (approximately 15% of time)

Education and Experience

• Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred.
• Minimum of 5 years of progressively responsible quality assurance experience within the biotech, IVD, or medical device industry, including independent ownership of quality system activities or cross-functional quality projects.
• Demonstrated practical experience applying ISO 13485:2016 and FDA Quality Management System Regulation (QMSR; 21 CFR Part 820), including quality records, CAPA, nonconformances, change control, and audit readiness.
• Hands-on experience administering and maintaining eQMS software, controlled document workflows, and training records; working knowledge of risk-based software validation, data integrity, and electronic records and electronic signature requirements under 21 CFR Part 11 where applicable.
• Familiarity with regulatory submissions, including EU IVDR and FDA requirements.

Skills and Competencies

• Strong understanding of quality management principles and regulatory requirements for biotech and IVD products.
• Proficiency in coordinating and reviewing technical files, including risk management and design documentation.
• Excellent organizational and project management skills.
• Strong communication skills with the ability to train and guide teams on quality documentation and compliance.
• Detail-oriented with a strong focus on accuracy and compliance.
• Problem-solving skills with a proactive approach to process improvement.

Knowledge and Skills – Preferred

• Practical experience applying ISO 14971 risk management principles, including hazard analysis, FMEAs, and verification of risk control effectiveness, preferred.
• Strong internal auditing skills.
• Direct experience with IVD technical documentation, EU IVDR requirements, and design and development records preferred.
• Experience independently planning and conducting internal audits preferred; ASQ Certified Quality Auditor, Certified Quality Engineer, or ISO 13485 lead auditor training preferred.
• Familiarity with CLSI guidelines for IVD analytical performance evaluation (e.g., precision, linearity, and detection capability) preferred.

Supervisory Responsibility

This position has no supervisory responsibility.

The work environment is primarily office-based with some exposure to laboratory and manufacturing settings. Laboratory and manufacturing areas may require the use of personal protective equipment (PPE) and adherence to biosafety and chemical safety procedures. Some laboratory experience is preferred.

Position Type/Expected Hours of Work

This position is onsite, full-time, Monday through Friday.