Agile Search Inc. · 11 hours ago
Quality Engineer - Medical Device Manufacturing
San Diego, CA
Full-time
Onsite
Mid, Senior Level
3+ years expAgile Search Inc. is a global leader in advanced engineering and product development in the medical device industry. They are seeking a Quality Engineer to provide quality support and manage the interface between the company and its customers, while applying Quality Engineering techniques and ensuring compliance with industry standards.
Human Resources
Hiring Manager
John Compton
Responsibilities
Serve as a lead Quality Engineer on development projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds
Monitoring and disseminating customer quality alerts and process deviations
Generating process deviations, Customer Change Notices, validation protocols & reports
Lead troubleshooting Quality opportunities during product launches and assisting with the Product Development Process
Leading development of metrology equipment
Developing and maintaining quality/control plans and PFMEA
Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product and process development process
Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs
Conducting Gage R&R studies and Design of Experiments
Developing Quality Procedures and conducting training to all personnel as appropriate
Approving Nonconformance disposition
Analyzing production and validation data with advance statistics
Working on continual improvement and process assessment projects as assigned
Authoring protocols or providing support in performing qualification validation protocols in support of design control deliverables
Qualification
Required
Minimum of 3 years' experience in a Quality Engineering role for a medical device manufacturer and/or high regulated technology manufacturing company
Working knowledge of Statistical software
Bachelor's degree (preference for engineering or related technical discipline)
Interact with customer and supplier companies in a professional manner; proactively communicates to ensure an ongoing two-way exchange of information
Experience with databases and Business Intelligence (PowerBi, Tableau, etc)
Experience managing multiple priorities, tasks and projects among various stakeholders
Preferred
CQE and/or Six Sigma Green or Black belt preferred (but not required)
Company
Agile Search Inc.
The Agile Search mission is to help our partner companies build unstoppable teams.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
John Compton
Founder and President
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