Senior Quality Engineer

Agendia•Irvine, CA

About The Position

The Senior Quality Engineer ensures products meet specifications and are developed and manufactured to high quality standards and applicable product quality, design, and manufacturing process requirements. The role provides process engineering and product quality assurance support to drive continuous process and product improvements. It organizes activities within the QA/RA Department and cooperates with departments across the organization, internal and external stakeholders, vendors, suppliers, and project and working groups. The position reports to the Senior Director, QA/RA. The role applies quality engineering tools and regulatory requirements to product development, manufacturing, supplier quality, design controls, risk management, post-market surveillance, audits, and quality system activities. It also serves as a backup Person Responsible for Regulatory Compliance (PRRC) and backup Management Representative, with responsibilities related to product release and regulatory reporting under the quality management system.

Requirements

Bachelor’s degree or above in Quality, Life Science, Biology, Pharmacy, Biomedical Engineering, Statistics, or a related technical discipline.
ASQ Certified Quality Engineer, Reliability Engineer, or Software Engineer certification required.
At least 3 years of expertise in Regulatory Affairs or Quality Management Systems for medical devices.
Knowledge of ISO 13485, ISO 14971, IVDR, and 21 CFR 820.
Knowledge of analytical and statistical principles, quality system standards, and root-cause investigation tools.
Project management skills and technical presentation skills.
Ability to interact with all levels of management and with employees, suppliers, and clients.
Strong verbal and written communication, critical thinking, problem-solving, interpersonal, and computer skills, including MS Office proficiency.
Ability to multitask, show initiative and flexibility, and maintain result and customer orientation.
Applicants must be currently authorized to work in the United States on a full-time basis without current or future sponsorship.

Nice To Haves

ASQ Certified Quality Auditor or another Lead Auditor certification.
Six Sigma Black Belt.
Experience with In Vitro Diagnostic, Class II, or Class III medical devices.
Knowledge of CAP/CLIA requirements.
Familiarity with supplier quality and contract manufacturing activities.

Responsibilities

Implement quality engineering tools throughout the organization, including lean principles, statistics, sampling plans, reliability engineering, software engineering, and design assurance techniques.
Conduct engineering activities in compliance with FDA regulations, ISO 13485, ISO 14971, IVDR, and other applicable national and international quality and regulatory requirements and standards.
Investigate issues and develop corrective and preventive actions based on engineering analysis and review, providing practical solutions for measurable continuous improvement.
Participate in design control activities, including risk management.
Coordinate post-market surveillance activities.
Author and manage quality agreements with mission-critical vendors and establish incoming inspection criteria, including verification versus vendor CoA protocols.
Analyze data, interpret results, and prepare protocols and reports documenting assigned work.
Support product quality activities using engineering tools and disseminate quality knowledge throughout the organization.
Support internal, external, and supplier audits, as well as quality metrics and management review activities.
Collaborate with supply chain and operations to improve supplier quality, delivery, process optimization, and total cost management; provide suppliers and other resources with technical assistance, training, and qualification or validation testing support.
Collaborate with Laboratory Operations, Product Development, and other departments on quality processes, product design and process testing, equipment and software qualification, validation, and risk management.
Work with procurement on supplier optimization, including identifying key suppliers based on competencies, qualifications, quality systems, and performance history.
Serve as backup Person Responsible for Regulatory Compliance (PRRC) and backup Management Representative.
Ensure device conformity is appropriately checked under the quality management system before release.
Ensure applicable IVDR reporting obligations are fulfilled, including serious incidents, field safety corrective actions, trend reporting, and vigilance-data analysis.
For qualifying performance studies involving risk to subjects, ensure the required statement under section 4.1 of Annex XIV of Regulation 2017/746 is issued.
Perform other duties as assigned.