Quality Engineer - Medical Device Manufacturing

This is a Full Time Onsite Quality Engineering opportunity in the 92121 zip code - the Sorrento Valley and Sorrento Mesa areas in northwestern San Diego, California.

Agile Search is partnered with a global leader in advanced engineering, prototyping and product development that is driving innovation across the medical device industry. With rapid expansion across multiple locations, this company continues to push the boundaries of technology while fostering a dynamic, employee-centered culture. It's an exciting place to be for professionals passionate about shaping the future of micro-manufacturing and being an integral part of the medical device industry.

The Quality Engineer (mid-Senior level) provides customer and factory facing quality support for managing the interface between the company and its customers, assisting with transition and sustaining of state of the art manufacturing processes, and support for the company's quality management system.

The incumbent in this important role applies Quality Engineering techniques and capabilities including:

Lean Six Sigma methodology, Process Validations and Verifications, Process Development and optimization, Gage R&R, along with ISO 13485 and/or 21CFR820 compliance.

Additional responsibilities include, but are not limited to:

• 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

Basic Requirements:

• 3-7 years of experience in a Quality Engineering or highly adjacent role (Manufacturing or Process Engineering) for a medical device manufacturer and/or high regulated technology manufacturing company
• Bachelor’s degree (preference for engineering or related technical discipline)
• Experience interacting 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); Working knowledge of Statistical software
• Experience managing multiple priorities, tasks and projects among various stakeholders.
• CQE and/or Six Sigma Green or Black belt preferred