Design Quality Engineer – IVD/Med Diagnostics

Caris Life Sciences; Tempe (AZ); Vor Ort; USD 85.000 - 115.000; Vollzeit

Zusammenfassung

Caris Life Sciences in Tempe, AZ is seeking a Design Quality Engineer to author quality deliverables, maintain the Design History File (DHF) and Risk File, and ensure compliance across the product lifecycle for in vitro diagnostics and laboratory developed tests.

You will collaborate with development, regulatory affairs, and cross-functional teams, performing risk assessments, creating documentation, and supporting inspection readiness in a fast-paced biomedicine environment.

Qualifikationen

• Bachelor’s degree in scientific, engineering or related field; 0–4 years experience in product development or diagnostics.
• Working knowledge of product development processes.
• Understanding of ISO 13485 quality management system requirements.
• Design controls experience (DHF, traceability, V&V) a plus.
• Experience with ISO 14971 risk management.
• Experience with oncology diagnostic development or LDT workflows.

Aufgaben

• Support New Product development, design changes and post launch activities as the Quality representative on sustaining projects.
• Create Technical records, review and approve Design History File
• Create and maintain the Risk Management records in alignment with quality system and regulatory requirements including design and use risk assessments.
• Perform Risk assessment for the Quality Events, Nonconformance and complaints.
• Able to work independently with minimal supervision.
• Can plan and coordinate work according to the project schedule.
• Support inspection readiness by providing risk management/DHF documentation and creating quality plan as needed.
• Support design changes to assess and document risk impact of product and process changes.

Kenntnisse

Product development processes

Quality management (ISO 13485)

Design controls experience

Risk management (ISO 14971)

Oncology diagnostic development

Ausbildung

Bachelor’s degree in scientific, engineering or related field

Jobbeschreibung

Caris Life Sciences in Tempe, AZ is seeking a Design Quality Engineer to author quality deliverables, maintain the Design History File (DHF) and Risk File, and ensure compliance across the product lifecycle for in vitro diagnostics and laboratory developed tests.

You will collaborate with development, regulatory affairs, and cross-functional teams, performing risk assessments, creating documentation, and supporting inspection readiness in a fast-paced biomedicine environment.