Quality Assurance Engineer

Design Assurance / Quality Assurance Engineer

Position Overview

We are seeking a skilled Design Assurance / QA Engineer to serve as the quality and regulatory expert in our R&D team. You will collaborate with hardware, software, and firmware engineers to ensure compliance throughout the product lifecycle, from concept to FDA submission. Your focus will be on maintaining design history files (DHF) for 510(k) submissions and ensuring adherence to medical device standards (ISO 14971, IEC 62304, IEC 62366, IEC 60601).

This is a proactive role within development, not a manufacturing-floor quality position. You will guide teams on quality, risk, and regulatory requirements while supporting smooth FDA submissions.

Key Responsibilities

• Design Control & Documentation:
• Provide guidance on FDA Design Controls, ISO 13485, and related standards.
• Lead design control activities (inputs, outputs, reviews, validation) and ensure traceability across the product lifecycle.
• Develop DHF templates and participate in design reviews with a focus on regulatory compliance.
• Risk Management (ISO 14971):
• Lead risk management across hardware and software, ensuring compliance with ISO 14971.
• Facilitate creation of risk management files (e.g., FMEA, FTA) and ensure traceability to design decisions.
• Software Lifecycle (IEC 62304):
• Guide software teams on compliance with IEC 62304, including development planning, requirements, and testing.
• Ensure software documentation (SRS, SDS) meets regulatory standards.
• Usability Engineering (IEC 62366):
• Support usability evaluations, ensuring integration of human factors in product design for FDA submissions.
• Electrical Safety (IEC 60601):
• Oversee compliance with IEC 60601-1 and related standards for hardware development, ensuring safety and performance.
• FDA Submissions & Compliance:
• Contribute to 510(k) submissions, ensuring complete, audit-ready documentation.
• Stay updated on FDA guidance and support pre-submission preparation.
• QMS Integration:
• Ensure R&D processes align with ISO 13485 QMS.
• Lead audit preparations and corrective actions, and improve design assurance processes.
• Training & Cross-Functional Guidance:
• Mentor engineering teams on regulatory expectations and best practices.
• Serve as the key liaison between R&D, Regulatory Affairs, and Quality Assurance.

Qualifications

Required:

• Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, Software)
• 5 years in design assurance or QA within medical device development
• Expertise in ISO 14971, IEC 62304, IEC 62366, IEC 60601
• Experience with FDA 510(k) submissions and design control processes
• Strong communication skills and attention to detail

Preferred:

• Experience with cardiac monitoring, ECG devices, or active medical devices
• ASQ Certified Quality Engineer or Regulatory Affairs Certification
• Familiarity with cloud-based platforms (e.g., SaaS/SaMD), AI/ML-based devices, and international regulatory standards (EU MDR, MDSAP)

Core Competencies

• Standards Mastery: Deep, practical knowledge of medical device standards applied during product development
• Regulatory Fluency: Expertise in structuring documentation for streamlined FDA submissions
• Collaboration: Ability to work closely with engineering teams while ensuring compliance
• Documentation Excellence: Producing clear, traceable, and audit-ready documentation
• Risk Management: Identifying and mitigating compliance risks early in the design process
• Continuous Improvement: Driving process improvements based on audits and lessons learned