Senior Associate, Quality Assurance

Full-time Regular
Mesa Ridge, San Diego, CA, US

Salary Range:
$35.10 To $45.19 Hourly

Job summary

The Senior Quality Assurance Associate plays a critical role in ensuring compliance with applicable regulations and standards, including QSR, ISO, and MDD. This position supports daily QA operations, product flow, and documentation reviews. Responsibilities include managing Change Control, Temporary Deviation, Engineering Testing, and Validation systems. This role also ensures that documentation SOPs align with regulatory standards, overseeing document release and control processes. Strong computer skills and exceptional written and verbal communication abilities are required. Additionally, the associate assists in generating metrics for upper management review.

Essential job functions and duties

• Maintains documentation for Quality System, ensuring accuracy and compliance.
• Develop and update Standard Operating Procedures related to Quality System activities.
• Assists with Change Order processing and release activities, serving as a backup to the Document Control Manager.
• Communicate Change Order information and collaborate with Manufacturing, Engineering, Quality, Clinical and Research & Development.
• Ensure departmental records, Quality Management System procedures, and corporate/external standards (e.g., ISO 13485, Vigilance) comply with FDA Quality Systems Regulations (QSR) and applicable foreign regulations (e.g., Medical Device Directive).
• Provides administrative and technical support to the Quality Systems Associate Director in the investigations of product failures, adverse events, or field complaints, adhering to FDA, MDD/MDR, and ISO 13485 requirements.
• Assists in the review, tracking and trending of returns per company policies and regulatory requirements.
• Performs data input and document scanning into the computer system for data collection purposes used to identify quality trends.
• Performs other related tasks as assigned.

Minimum requirements

• Associate’s degree (AA) or equivalent from two-year college or equivalent combination of education and experience. Bachelor’s degree preferred.
• 3 – 5 years of experience in medical device or pharmaceutical/ biotech industry, with a solid understanding of FDA and ISO regulations.
• Ability to read, analyze, and interpret technical procedures and regulations, as well as write reports and procedure manuals.
• Strong communication skills with the ability to effectively present information and respond to inquiries from managers, clients, customers, and the general public.
• Ability to solve practical problems and navigate situations with limited standardization.
• Knowledge of Document Control and Change Order Processing principles.
• 3-5 years of experience in Document Control, Change Order processing, Deviations, Complaints, CAPA, and validation processes.
• Strong organizational and project management skills, with the ability to execute tasks in a disciplined and consistent manner.
• Ability to work independently with minimum supervision individually, as well as collaboratively in a team environment.