Quality Assurance Engineer

Qnovia, Inc.; Newport Beach (CA); Hybrid; USD 110,000 - 145,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision insurance

Equity ownership in a pre-commercial stage company

401(k) with company match

Job summary

Qnovia, Inc. is seeking a Quality Assurance Engineer to develop and maintain quality management systems, ensuring compliance with FDA 21 CFR 820 and ISO 13485 regulations. The role is pivotal in advancing products through regulatory approval to commercial production.

Responsibilities include supporting design control activities, conducting internal audits, and managing corrective action processes. Candidates should have a Bachelor's degree and at least 5 years of quality assurance experience in medical device manufacturing. The position offers a salary range of $110,000 – $145,000 annually along with equity participation.

Qualifications

• 5+ years of quality assurance experience in medical device or pharmaceutical manufacturing.
• Experience with process validation (IQ/OQ/PQ) protocols.

Responsibilities

• Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820.
• Conduct internal audits and manage CAPA processes.
• Review and approve device master records, batch records, and engineering change orders.

Skills

Strong analytical and problem-solving skills

Experience with CAPA, NCR, and complaint handling systems

In-depth knowledge of FDA 21 CFR 820

Experience with electronic QMS platforms (MasterControl, Greenlight Guru, or equivalent)

Education

Bachelor's degree in engineering, life sciences, or related field

Job description

Develop and maintain quality management systems and ensure regulatory compliance across Qnovia's product development and manufacturing operations.

About the Role

Qnovia operates under a quality management system designed to meet FDA 21 CFR 820 and ISO 13485 requirements. As a Quality Assurance Engineer, you will be responsible for maintaining and continuously improving our QMS, supporting design control activities, and ensuring that all products meet established quality standards. This role is essential to our ability to advance products through regulatory approval and into commercial production.

Responsibilities

• Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820
• Support design control activities including design reviews, risk analysis, and design transfer
• Conduct internal audits and manage CAPA (Corrective and Preventive Action) processes
• Review and approve device master records, batch records, and engineering change orders
• Manage supplier qualification and incoming inspection programs
• Support regulatory inspections and external audits
• Develop and maintain quality metrics and management review reporting
• Investigate product complaints and nonconformances; drive root cause analysis and corrective actions

Qualifications

• Bachelor's degree in engineering, life sciences, or related field
• 5+ years of quality assurance experience in medical device or pharmaceutical manufacturing
• In-depth knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971
• Experience with CAPA, NCR, and complaint handling systems
• Strong analytical and problem‑solving skills
• Experience with electronic QMS platforms (MasterControl, Greenlight Guru, or equivalent)

Preferred Qualifications

• Experience with combination product quality requirements
• Background in design control for Class II or Class III medical devices
• Experience with process validation (IQ/OQ/PQ) protocols

$110,000 – $145,000 annually, depending on experience. Equity participation included.

• Comprehensive medical, dental, and vision insurance
• Equity ownership in a pre‑commercial stage company
• Flexible hybrid work arrangement
• 401(k) with company match

Qnovia, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

If you require a reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please contact us at [e-mail].

This job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Qnovia reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.