Sr. Quality Enginer (Robotics)

Senior Quality Engineer (Robotics)

San Francisco, CA

Company:

Our client is an innovative start-up company that is developing advanced, cloud-controlled robotic systems that enable the production of individualized drugs at scale. Their customers include some of the largest global organizations in the advanced pharmaceutical manufacturing space.

Based in San Francisco, California, our client is backed by many top-tier tech and life science investors, including Casdin Capital, Lux Capital, Y Combinator, and more.

Overview

This role will support the production of high quality robotic systems and consumables for

automated cell therapy manufacturing. The Quality Engineer works as an integral part of the

Multiply Labs engineering and product team and is responsible for the continual improvement of

process and product quality.

Responsibilities

• Lead efforts with Hardware Engineering, Manufacturing Engineering and product teams to establish quality performance metrics, ensuring internal documentation, manufacturing processes and tooling are consistent and complete to promote compliance and manufacturing readiness
• Use QA methodologies to manage and facilitate issue resolution including root cause investigations and development, implementation and monitoring of effective corrective and preventive actions
• Interface with external vendors, customers and in-house manufacturing team to define and execute a quality plan compliant with applicable regulatory requirements such as ISO and GMP
• Perform supplier qualification and external audits against customer quality requirements including first article inspection
• Perform internal audits against released manufacturing processes and procedures
• Lead quality data collection, analysis, reporting and issue resolution during FAT, SAT, IQ, OQ and other major production or deployment milestones
• Establish and maintain control plans to assure critical features are controlled through the assembly/production processes
• Support the development of Design and Process FMEA
• Lead/facilitate review and disposition of discrepant materials identified for control of nonconforming product
• Lead/perform product containment activities and arrange for disposition
• Support and generate continuous improvement ideas and work on cost reduction projects

Skills:

• First principles problem-solving skills
• Self-motivated, driven individual capable of working independently and in team settings
• Ability to communicate technical information to both technical and non-technical stakeholders.
• Familiarity with GD&T, Good Manufacturing Practice (GMP) compliance and ISO compliance
• Familiarity with clean room procedures and associated equipment
• Familiarity with 6-axis robots and motion controlled automated systems
• Ability to create and interpret engineering drawings for mechanical and electrical systems

Qualifications:

• Bachelor’s Degree in Mechanical Engineering or with equivalent experience
• 4+ years of experience in a technical quality role supporting design, manufacturing and NPI
• Excellent analytical skills; attention to detail, spreadsheet and database management skills; strong general computer skills