Design Quality Assurance Engineer

Position Summary

We are seeking an experienced Design Quality Assurance Engineer with medical device experience to support design quality activities focused on change management, design changes, design controls, and documentation remediation.

This role will be responsible for reviewing existing design, validation, and quality system documentation; identifying gaps or deficiencies; supporting impact assessments; and helping ensure design changes are properly documented, reviewed, and implemented in compliance with applicable regulatory and internal quality system requirements.

The ideal candidate will have strong experience with design controls, change control, design change assessments, DHF documentation, risk-based review, validation documentation, and remediation of quality system records in a regulated medical device environment.

Key Responsibilities

• Review and assess current design, validation, and quality system documentation for completeness, traceability, and compliance.
• Support change management activities related to product, process, software, hardware, labeling, and documentation updates.
• Evaluate design changes for compliance with design control, risk management, and quality system requirements.
• Support impact assessments related to design changes, including potential effects on verification, validation, risk management, labeling, released documentation, and DHF records.
• Identify documentation gaps, deficiencies, and inconsistencies associated with change records, validation documentation, and design history documentation.
• Partner with Engineering, Quality, Regulatory, and other cross-functional teams to correct deficiencies and ensure compliant implementation of changes.
• Review and support updates to DHF documentation, traceability matrices, validation records, protocols, reports, and change documentation.
• Ensure change documentation aligns with internal procedures and applicable FDA and ISO requirements.
• Support remediation and audit-readiness activities associated with legacy design and validation documentation.
• Provide Design Quality Assurance input during review and approval of design changes and associated records.

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Strong Design Quality Assurance or Design Quality Engineering experience in the medical device industry.
• Experience with change management, design change control, and design controls.
• Experience reviewing, assessing, and remediating quality system, design, and validation documentation in regulated environments.
• Familiarity with DHF documentation, traceability, risk management, verification, validation, and documentation impacts of design changes.
• Strong technical writing, documentation review, and problem-solving skills.
• Ability to work cross-functionally to identify and resolve documentation, compliance, and quality system gaps.
• Ability to work onsite in Carlsbad, CA.

Preferred Qualifications

• Experience with catheter systems, consoles, or similar electromechanical medical device platforms.
• Experience supporting remediation, gap assessments, audit-readiness, or legacy documentation cleanup initiatives.
• Familiarity with FDA and ISO-regulated medical device environments, including ISO 13485 and design control requirements.
• Experience supporting verification and validation impact assessments related to design changes.
• Experience working with Class II or Class III medical devices.

Ideal Candidate Profile

• Detail-oriented and highly organized.
• Strong understanding of design assurance and change control requirements.
• Comfortable reviewing technical documentation and identifying compliance gaps.
• Able to work independently in a fast-paced remediation environment.
• Strong communicator with the ability to coordinate effectively across Quality, Engineering, Regulatory, and program stakeholders.