Design Quality Engineer: IVD & Risk Management

Caris MPI, Inc.; Phoenix (AZ); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

Caris Life Sciences in Phoenix is seeking a Design Quality Engineer to author quality deliverables, maintain the design history file, and manage risk records throughout the product lifecycle for NGS/IVD diagnostics.

The role collaborates with Development, Regulatory Affairs, and operations to ensure design controls are applied and compliance maintained in a fast-paced environment. A 0–4 year track record in product development within IVD/biotech is preferred.

Qualifikationen

• Bachelor’s degree in science or engineering or related field.
• 0–4 years of product development or IVD experience.
• Knowledge of ISO 13485 QMS requirements.

Aufgaben

• Author quality deliverables and maintain the DHF and Risk File.
• Collaborate with cross-functional teams across lifecycle activities.
• Support New Product development and post-launch as QA representative.
• Perform risk assessments per ISO 14971 and quality system.

Kenntnisse

Quality mindset

Regulatory awareness

Independent work

Cross-functional collaboration

Ausbildung

Bachelor’s degree in science or engineering

Tools

Traceability matrices

V&V documentation

Design reviews

Jobbeschreibung

Caris Life Sciences in Phoenix is seeking a Design Quality Engineer to author quality deliverables, maintain the design history file, and manage risk records throughout the product lifecycle for NGS/IVD diagnostics.

The role collaborates with Development, Regulatory Affairs, and operations to ensure design controls are applied and compliance maintained in a fast-paced environment. A 0–4 year track record in product development within IVD/biotech is preferred.