Senior Quality Assurance Leader – Medical Diagnostics

Connexis Search Group; Irvine (CA); Presencial; USD 120.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid time off

Holidays

Cutting-edge diagnostic technology

Career growth opportunities

Impact on global infectious disease

Descripción de la vacante

Connexis Search Group in Irvine, CA seeks a Senior Quality Assurance Specialist to lead QMS improvements aligning with FDA 21 CFR Part 820 and ISO 13485. The role works cross-functionally to ensure product quality and drive continuous improvement in a regulated environment.

On-site requirement at the Irvine facility with strong data-driven decision-making. You will drive internal audits, CAPA, supplier quality, and lifecycle quality across R&D, Manufacturing, Regulatory, and Commercial teams,

Formación

• 3–5 years of quality experience in medical device/IVD industry.
• Master's degree: 2–3 years; PhD: 1–2 years experience.
• Good knowledge of FDA QMSR, ISO 13485:2016, and ISO 14971:2019.
• Experience with supplier management and internal/external audits.
• Hands-on experience with eQMS tools (e.g., Agile, Greenlight Guru, IQS, MasterControl, Veeva Vault).
• On-site availability at Irvine, CA facility (no remote option).

Responsabilidades

• Lead internal audit program and CAPA program management.
• Develop and continuously improve quality system processes to meet regulatory and business requirements.
• Support reporting of quality performance, compliance status, risks, and trends.
• Support external audits and inspections by regulatory bodies.
• Oversee supplier quality management, qualification, auditing, and KPIs.
• Lead SCAR processes and drive root cause investigations and systemic CAPA.
• Oversee design controls, V&V, and lifecycle management for product development and regulatory submissions.
• Collaborate with R&D, Manufacturing, Regulatory, and Commercial teams to integrate quality across product realization.

Conocimientos

Quality Assurance

Internal Audits

CAPA Management

Data Analysis

Statistical Methods

Regulatory Knowledge

Cross-functional Collaboration

Communication Skills

On-site Availability

Educación

Bachelor's degree in Life Sciences

Master's degree in related field

PhD in related field

Herramientas

Agile eQMS

Greenlight Guru

IQS

MasterControl

Veeva Vault

Descripción del empleo

Connexis Search Group in Irvine, CA seeks a Senior Quality Assurance Specialist to lead QMS improvements aligning with FDA 21 CFR Part 820 and ISO 13485. The role works cross-functionally to ensure product quality and drive continuous improvement in a regulated environment.

On-site requirement at the Irvine facility with strong data-driven decision-making. You will drive internal audits, CAPA, supplier quality, and lifecycle quality across R&D, Manufacturing, Regulatory, and Commercial teams,