Quality Engineer, Medical Devices & Regulatory Compliance

Venova Medical, Inc.; Los Gatos (CA); On-site; USD 135,000 - 165,000; Full time

Job summary

Venova Medical, Inc. is seeking a Quality Engineer to own QA activities for a high-risk Class III medical device under clinical trials.

You will ensure compliance with FDA QMSR, ISO 13485/14971, and related regulations, partnering with R&D, Operations and Clinical Affairs to release safe and effective devices. Responsibilities include maintaining the quality system, conducting data analysis, leading CAPA and investigations, and supporting supplier qualification and document control in a

Qualifications

• BS Engineering with 4+ years in medical device or related environment.
• Familiar with FDA 21 CFR Part 820 QMSR, ISO 13485, and ISO 14971.
• Experience with precision measurement tools and basic statistical sampling.

Responsibilities

• Support quality operations to ensure compliance with regulations; provide training on quality awareness.
• Contribute to quality initiatives to ensure effectiveness of the quality management system; data analysis and audits.
• Perform document control tasks and ensure timely release of documents and change orders.
• Lead root-cause investigations and CAPA activities with a risk-based approach.
• Qualify suppliers and monitor performance to meet requirements; support product/process changes.

Skills

Quality principles

Data analysis

Root cause analysis

Communication

Team collaboration

Statistical sampling

Education

BS Engineering

Job description

Venova Medical, Inc. is seeking a Quality Engineer to own QA activities for a high-risk Class III medical device under clinical trials.

You will ensure compliance with FDA QMSR, ISO 13485/14971, and related regulations, partnering with R&D, Operations and Clinical Affairs to release safe and effective devices. Responsibilities include maintaining the quality system, conducting data analysis, leading CAPA and investigations, and supporting supplier qualification and document control in a