Quality Engineer II

(SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations.

Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

Job Title:
Quality Engineer II

Job Location:

Irvine, CA - Considering candidates who reside in or are within a reasonable commuting distance of Irvine, CA
Job Duration: 12 Months

Job Summary:
The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties:

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
• Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
• Proficient in project management, data analysis, root cause analysis, communication, and risk determination
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Minimum Requirements:

• Bachelor's degree in Engineering
• 3 years of relevant experience in a regulated industry (manufacturing, medical device, or medical device manufacturing preferred)
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
• Bachelor's degree in Engineering