Principal Quality Engineer

DIALITY INCIrvine, CA, US

2 days ago

Job type

Full-time

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

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.

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Principal Quality Engineer • Irvine, CA, US