Senior Quality Engineer, Medical Devices (Design Control)

Noctrix-Health; Pleasanton (CA); Hybrid; USD 150,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Pleasanton headquarters

Job summary

Noctrix Health in Pleasanton seeks a Senior Quality Engineer to lead Design Control across new product development and sustaining changes for our medical device portfolio.

You will partner with Regulatory, Engineering, and Manufacturing to drive verification/validation, risk management, change control, and CAPA, while ensuring compliance with FDA and ISO requirements in a hybrid work environment. The role reports to the Director, Quality.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality or related field.
• Minimum of 6 years of Quality Engineering experience in medical devices.
• Experience leading Design Control within medical device development and changes.
• Strong knowledge of FDA Design Control, ISO 13485, ISO 14971, risk management, V&V, design transfer, and change control.

Responsibilities

• Serve as Design Control SME and advise on application of SOPs, regulatory requirements, and design control best practices.
• Lead Quality representation for NPD and sustaining product changes across hardware, firmware, software, labeling, components, and manufacturing updates.
• Guide teams through design planning, design inputs/outputs, reviews, verification/validation, transfer, changes, tracing, and risk management.
• Review proposed changes and advise on design control, risk management, verification, validation, and documentation requirements.
• Own or support CAPA and nonconformance investigations, root cause analysis, corrective actions, and effectiveness evaluations.

Skills

Design Control SME

Regulatory Compliance

Risk Management

Verification & Validation

Design Transfer

CAPA

Documentation & Writing

Cross-functional Leadership

Education

Bachelor’s degree in Engineering/Life Sciences

Job description

Noctrix Health in Pleasanton seeks a Senior Quality Engineer to lead Design Control across new product development and sustaining changes for our medical device portfolio.

You will partner with Regulatory, Engineering, and Manufacturing to drive verification/validation, risk management, change control, and CAPA, while ensuring compliance with FDA and ISO requirements in a hybrid work environment. The role reports to the Director, Quality.