QA Engineer, Medical Devices & Regulatory QMS

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

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.