Principal Quality Engineer

Job Description

Job Description

Company & Job Overview :

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Principal Quality Engineer will play a critical role in ensuring the ongoing safety, efficacy, and compliance of our medical devices after they have entered the market. This senior-level role provides technical leadership and strategic oversight of post-market quality activities, including complaint handling, vigilance reporting, post-market surveillance, risk management, and continuous product improvement. The Principal Quality Engineer serves as a subject matter expert (SME) on post-market regulatory requirements and partners cross-functionally to ensure timely, effective, and compliant execution of quality system processes.

Responsibilities :

• Lead and oversee post-market surveillance programs to monitor product performance, safety trends, and emerging risks.
• Provide technical leadership for root cause analysis of customer complaints, field issues, and adverse events.
• Ensure timely evaluation, investigation, and closure of complaints in compliance with FDA, ISO 13485, and other global regulations.
• Collaborate with R&D, Manufacturing, and Service teams to drive effective corrective and preventive actions (CAPA).
• Partner with regulatory affairs to manage global adverse event reporting requirements.
• Collaborate with Clinical, Regulatory, and Field Service teams to strengthen the post-market surveillance.
• Support supplier quality, process validation, and production controls to ensure consistent compliance with ISO 13485 and FDA QSR requirements.
• Act as SME for design transfer to manufacturing, ensuring quality requirements are met.

Required Skills & Abilities

Education & Experience

Travel

Physical Requirements