Senior Quality Engineer

Agendia Inc.•Irvine, CA

9d•$125 - $150

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 supports process engineering and product quality assurance to drive continuous process and product improvements, and organizes activities within the QA/RA Department. It reports to the Senior Director, QA/RA and works with departments across the organization, internal and external stakeholders, vendors, suppliers, and project teams. The position applies quality engineering tools throughout the organization, supports design controls and risk management, coordinates post-market surveillance, investigates quality issues and develops corrective and preventive actions, and authors and manages supplier quality agreements and documentation. It supports audits, quality metrics, management reviews, product release, and quality and regulatory compliance. It also collaborates with laboratory operations, product development, supply chain, operations, and procurement on testing, validation, supplier performance, and continuous improvement. QA/RA-specific responsibilities include serving as PRRC and Management Representative, with backup duties for both roles. Responsibilities include ensuring device conformity is checked before release under the QMS, ensuring applicable IVDR reporting obligations are fulfilled—including serious incidents, field safety corrective actions, trend reporting, and vigilance-data analysis—and issuing the specified statement for certain performance studies. The role may work in a laboratory environment as needed and involves less than 20% travel. Applicants must be authorized to work in the United States full-time without current or future sponsorship.

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; experience with In Vitro Diagnostic, Class II, or Class III medical devices is preferred.
Knowledge of ISO 13485, ISO 14971, IVDR, and 21 CFR 820.
Knowledge of analytical and statistical principles, quality system standards, root cause investigation tools, and customer-focused quality process improvement.
Project management and technical presentation skills.
Ability to interact with all levels of management, employees, suppliers, and clients.
Familiarity with supplier quality and contract manufacturing activities.
Excellent verbal and written communication skills; ability to multitask; computer proficiency such as MS Office; critical thinking; problem-solving, interpersonal, presentation, and project management skills; result and customer orientation; initiative; flexibility; and a can-do attitude.
Must be able to read and understand scientific and complex directions.
Specific vision abilities include close, distance, and color vision.
Must be currently authorized to work in the United States on a full-time basis without current or future sponsorship.
Employees must not be classified as an excluded individual prohibited from participation in any Federal health care program.

Nice To Haves

ASQ Certified Quality Auditor or other Lead Auditor certification.
Six Sigma Black Belt.
Knowledge of CAP/CLIA requirements.
Experience with In Vitro Diagnostic, Class II, or Class III medical devices.

Responsibilities

Implement quality engineering tools across 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.
Conduct investigations and develop corrective and preventive actions based on engineering analysis and review, providing practical solutions that deliver measurable improvements.
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 against vendor CoA protocols.
Analyze data, interpret results, and write protocols and reports documenting assigned work.
Support product quality activities through engineering tools and dissemination of knowledge throughout the organization.
Support internal, external, and supplier audits.
Support quality metrics and management review activities.
Collaborate with supply chain and operations on supplier quality, delivery, process optimization, and total cost improvement; provide technical assistance and support training and qualification/validation testing.
Collaborate with Laboratory Operations, Product Development, and other departments on quality processes, product and process testing, equipment/software qualification, validation, and risk management.
Collaborate 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 serve as PRRC and Management Representative, including backup Management Representative duties.
Ensure device conformity is appropriately checked under the QMS before product 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, ensure the statement specified in section 4.1 of Annex XIV of Regulation 2017/746 is issued.
Perform other duties as assigned.