Lead Quality Assurance Engineer

Lake Forest, California

Lumicity

Overview:

Provide expert guidance to design teams on quality assurance, design controls, specifications, testing methodologies, usability, and risk management strategies.
Champion quality considerations during design and technical reviews to ensure compliance with established procedures.
Take charge of managing Design History Files (DHF) and Device Master Records (DMR) to guarantee regulatory compliance.
Lead risk analysis and implement controls that prioritize product safety throughout the development process.
Collaborate effectively with cross-functional teams to integrate quality into all stages of product development and support.
Define appropriate sample sizes for testing and inspections, utilizing a risk-based approach to decision-making.
Apply statistical methods and quality tools to validate product reliability and compliance with regulations.
Direct Corrective and Preventive Action (CAPA) investigations, ensuring timely follow-up on corrective actions.
Identify and drive improvements in testing, design, and documentation processes to enhance overall quality.
Assist in conducting audits and preparing regulatory submissions with a focus on design control and risk management.
Support additional quality system responsibilities and tasks as assigned.

Requirements:

Bachelor's degree with a minimum of 4 years of experience in quality assurance within the medical device industry.
Comprehensive knowledge of Design Controls (21 CFR 820.30) and Risk Management (ISO 14971).
Proficient in determining sample sizes for testing and inspection purposes.
Exceptional communication, organizational skills, and attention to detail.
Ability to interpret technical documentation, including schematics and test plans.
Experience with CAPA processes and risk assessments.
Strong interpersonal and negotiation abilities to foster collaboration.

Date Posted: 12 May 2025