Principal Quality Engineer

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

• Deep knowledge of global quality and regulatory standards, including ISO 13485, ISO 14971, and FDA QMSR.
• Expertise in post-market quality system activities, including complaint handling, vigilance/adverse event reporting, health hazard evaluations (HHE), and post-market surveillance.
• Demonstrated ability to conduct and lead complex investigations and implement effective corrective and preventive actions (CAPA).
• Skilled in structured problem-solving techniques such as (i.e. 8D, Fishbone, DMAIC, etc.).  
• Strong command of statistical methods (DOE, regression, sampling plans, capability analysis).
• Collaborative mindset with the ability to build partnerships across R&D, Regulatory, Operations, and Clinical teams.
• Effective verbal and written communication skills.

Education & Experience

• Bachelor’s degree in Engineering, Life Sciences, or related field (advanced degree preferred).
• 15 years of progressive quality engineering experience in the medical device industry, with demonstrated expertise in design, manufacturing, and post-market quality systems.
• Strong knowledge of FDA Quality System Regulation, ISO 13485, and other relevant standards.
• Proven success in complaint handling, risk management, and CAPA execution.
• Experience with complex electromechanical devices preferred.

Travel

• Occasional travel required  

Physical Requirements

• Use of personal protective equipment (PPE) may be required depending on work area.