Senior Design Assurance Quality Engineer
Kforce Inc.

Job Info

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RESPONSIBILITIES:

Kforce has a client in Irvine, CA that is seeking a Senior Design Assurance Quality Engineer.Responsibilities:

• Supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices
• Focuses on process, equipment, and design verification and validations
• Working with teams to develop manufacturing and quality processes and define their related tools
• Troubleshooting and support of manufacturing floor and field issues, and review and approve validations
• Review and approve verification and validation protocols and reports
• Participate in Change Control review and approval activities as required
• Provide technical guidance and oversight to Quality Engineers
• Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971
• Develop and implement quality plans
• Ensure post market surveillance reviews are conducted and reports documented according to schedule
• Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues
• Provide key quality trending information and data for Management Review and monthly KPI review, as applicable
• Represent quality interests and concerns on project teams
• Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes
• Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.
• Provide support during regulatory audits and responses to government agency questions

REQUIREMENTS:

• Bachelor's degree in Engineering or technical discipline required
• 5 years of medical device experience
• Proficient with Microsoft Office Suite
• Familiarity with mechanical and electrical test equipment
• Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
• Working knowledge of EN ISO 13485, ISO 14971 and FDA QSR for Medical Devices (Regulations)
• Ability to work in a fast-paced environment
• High energy problem solver capable of driving items to closure
• Excellent communication and interpersonal skills (verbal, written and presentation)
• Understands how to present information dependent on the level of the audience
• Ability to effectively manage time, balance multiple task assignments and translate quality requirements into product specifications
• Understands basic applied statistics, statistical sampling plans and statistical process control
• Familiar with Minitab Statistical Analysis Software (or equivalent)

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