Senior Quality Engineer

Job Title: Quality Engineer – FDA Remediation

Location: Carlsbad, CA (Onsite)

Duration: Long-Term Contract

2 Manger References must

Job Summary

We are seeking an experienced Quality Engineer with a strong background in FDA Remediation within the medical device industry. The ideal candidate will have 8 years of Quality Engineering experience supporting FDA remediation initiatives, Quality Management Systems (QMS), Design Controls, CAPA, and regulatory compliance activities. The candidate should be capable of working independently with cross-functional teams to drive remediation projects and ensure compliance with FDA regulations and industry standards.

Key Responsibilities

• Support and execute FDA remediation projects to address regulatory observations and quality system improvements.
• Review, update, and remediate Quality System documentation to ensure compliance with FDA regulations and applicable standards.
• Perform gap assessments against regulatory requirements and develop remediation plans.
• Support CAPA investigations, root cause analysis, and effectiveness verification.
• Review and remediate Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and technical documentation.
• Collaborate with Quality, Regulatory, Manufacturing, R&D, and Operations teams to resolve compliance issues.
• Participate in internal audits, supplier quality activities, and inspection readiness initiatives.
• Support change control activities, risk assessments, and validation documentation as needed.
• Ensure compliance with FDA Quality System Regulation, ISO 13485, and applicable medical device regulations.
• Prepare reports and provide updates on remediation progress to project leadership.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 8 years of Quality Engineering experience in the medical device or regulated healthcare industry.
• Proven experience leading or supporting FDA Remediation projects.
• Strong understanding of:
• FDA Quality System Regulation (21 CFR Part 820/QMSR)
• ISO 13485
• CAPA
• Nonconformance Management
• Design Controls
• Risk Management
• Document Control
• Change Control
• Internal and External Audits
• Experience working with Design History Files (DHF), Risk Files, and Quality Records.
• Excellent analytical, problem-solving, documentation, and communication skills.
• Ability to work effectively with cross-functional teams in a fast-paced environment.

Preferred Qualifications

• Experience supporting FDA inspections, warning letter remediation, or consent decree remediation projects.
• Familiarity with eQMS platforms such as TrackWise, Veeva, MasterControl, Greenlight Guru, or similar systems.
• ASQ Certified Quality Engineer (CQE) or related quality certification is a plus.
• Knowledge of risk management principles and regulatory standards applicable to medical devices.

Mandatory Requirements

• Minimum 8 years of relevant Quality Engineering experience.
• Hands-on FDA Remediation experience is mandatory.
• Two managerial references are mandatory and will be required during the interview process.
• Ability to work onsite in Carlsbad, CA.