Quality Engineer - Medical Device Manufacturing

Agile Search Inc.; San Diego (CA); Sur place; USD 85 000 - 130 000; Plein temps

Résumé du poste

Agile Search is seeking a mid–senior Quality Engineer for an onsite role in San Diego (92121). You will support customer and factory quality interfaces, drive transition and sustaining of manufacturing processes, and uphold QMS compliance.

The position emphasizes Lean Six Sigma, design/document control, PFMEA, Gage R&R and regulatory standards. The role requires 3–7 years in medical device quality engineering, a engineering degree, and strong communication with customers and suppliers.

Qualifications

• 3–7 years of experience in Quality Engineering or adjacent role in medical device/manufacturing.
• Bachelor’s degree in engineering or related discipline.
• Experience interacting with customers and suppliers in a professional manner.
• Experience with databases and BI tools; working knowledge of statistical software.
• Experience managing multiple priorities among stakeholders.
• CQE and/or Six Sigma Green or Black Belt preferred.

Responsabilités

• Serve as a lead Quality Engineer on development projects; contribute to Design History File/Device Master Record and product builds.
• Monitor and disseminate customer quality alerts and process deviations.
• Lead troubleshooting during product launches and support Product Development Process.
• Lead development of metrology equipment.
• Develop and maintain quality/control plans and PFMEA.
• Ensure QMS procedures and regulations are used in development.
• Develop risk documentation per QMS and regulatory standards (e.g., PFMECA).
• Conduct Gage R&R studies and Design of Experiments.
• Develop Quality Procedures and train personnel.
• Approve nonconformance disposition.
• Analyze production and validation data with advanced statistics.
• Support continual improvement and process assessment projects.
• Author protocols or support qualification/validation in design control.

Connaissances

Lean Six Sigma

Quality Engineering

Gage R&R

Process Validation

Process Development

Statistical software

Customer interaction

ISO 13485

21 CFR 820

Formation

Bachelor’s degree in engineering or related discipline

Outils

Power BI

Tableau

Statistical software

Description du poste

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
• 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