Sr. Quality Assurance Engineer - Medical Device Regulatory

Our client is redefining what's possible in medical technology. Their team is dedicated to developing innovative medical devices that improve patient outcomes and set new standards for safety, efficacy, and usability. They are seeking a highly experienced and detail-oriented?Senior Quality Assurance Engineer?to join their growing Quality team and play a key role in ensuring compliance across our product lifecycle.

As a Senior Quality Assurance Engineer, you will be a subject matter expert in regulatory assurance, design control, manufacturing quality, and quality management system (QMS) administration. You will ensure our devices meet all applicable FDA, ISO 13485, and other global regulatory requirements, and will support cross-functional teams to maintain product quality throughout design, development, and commercial manufacturing.

Key Responsibilities:

• Lead quality assurance activities across the product lifecycle in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory standards.
• Serve as Quality representative on cross-functional teams for product development, risk management, and design transfer.
• Develop, review, and approve design history file (DHF) documentation including design inputs, outputs, verification and validation, and design reviews.
• Drive implementation and continuous improvement of Design Control processes.
• Support manufacturing and operations teams in implementing in-process controls, root cause investigations, and corrective/preventive actions (CAPA).
• Manage and improve QMS documentation and processes including document control, training, nonconformances, supplier quality, internal audits, and change management.
• Assist in regulatory submissions by providing quality input and documentation support.
• Prepare for and participate in internal and external audits (FDA, ISO notified bodies, customers).
• Train team members on QMS procedures and support company-wide quality awareness.

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 5+ years of quality assurance experience in the medical device industry.
• Deep knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and applicable international standards.
• Proven experience in Design Controls, risk management, and design verification/validation.
• Experience supporting manufacturing quality and process validation (IQ/OQ/PQ).
• Strong understanding of QMS platforms and document control systems (e.g., MasterControl, Greenlight Guru, Veeva, or similar).
• Excellent documentation, analytical, and communication skills.

Preferred Qualifications:

• Experience with Class II or Class III medical devices.
• Lead Auditor certification (ISO 13485) is a plus.
• Familiarity with EU MDR, MDSAP, and other international regulatory frameworks.
• Prior experience in a start-up or rapid-growth environment is highly desirable.

The Offer:

• Competitive salary, bonus structure, and equity package.
• Comprehensive health benefits and 401(k).
• A mission-driven company culture focused on innovation, safety, and impact.
• Opportunities for professional development and advancement.
• Work that makes a tangible difference in people's lives.