HealthCare Recruiters International
Sr. Quality Enginer (Robotics)
HealthCare Recruiters International, San Francisco, California, United States, 94101
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.
OverviewThis role will support the production of high quality robotic systems and consumables forautomated cell therapy manufacturing. The Quality Engineer works as an integral part of theMultiply Labs engineering and product team and is responsible for the continual improvement ofprocess and product quality.
ResponsibilitiesLead 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 readinessUse QA methodologies to manage and facilitate issue resolution including root cause investigations and development, implementation and monitoring of effective corrective and preventive actionsInterface 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 GMPPerform supplier qualification and external audits against customer quality requirements including first article inspectionPerform internal audits against released manufacturing processes and proceduresLead quality data collection, analysis, reporting and issue resolution during FAT, SAT, IQ, OQ and other major production or deployment milestonesEstablish and maintain control plans to assure critical features are controlled through the assembly/production processesSupport the development of Design and Process FMEALead/facilitate review and disposition of discrepant materials identified for control of nonconforming productLead/perform product containment activities and arrange for dispositionSupport and generate continuous improvement ideas and work on cost reduction projects
Skills:First principles problem-solving skillsSelf-motivated, driven individual capable of working independently and in team settingsAbility to communicate technical information to both technical and non-technical stakeholders.Familiarity with GD&T, Good Manufacturing Practice (GMP) compliance and ISO complianceFamiliarity with clean room procedures and associated equipmentFamiliarity with 6-axis robots and motion controlled automated systemsAbility to create and interpret engineering drawings for mechanical and electrical systems
Qualifications:Bachelor’s Degree in Mechanical Engineering or with equivalent experience4+ years of experience in a technical quality role supporting design, manufacturing and NPIExcellent analytical skills; attention to detail, spreadsheet and database management skills; strong general computer skills
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.
OverviewThis role will support the production of high quality robotic systems and consumables forautomated cell therapy manufacturing. The Quality Engineer works as an integral part of theMultiply Labs engineering and product team and is responsible for the continual improvement ofprocess and product quality.
ResponsibilitiesLead 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 readinessUse QA methodologies to manage and facilitate issue resolution including root cause investigations and development, implementation and monitoring of effective corrective and preventive actionsInterface 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 GMPPerform supplier qualification and external audits against customer quality requirements including first article inspectionPerform internal audits against released manufacturing processes and proceduresLead quality data collection, analysis, reporting and issue resolution during FAT, SAT, IQ, OQ and other major production or deployment milestonesEstablish and maintain control plans to assure critical features are controlled through the assembly/production processesSupport the development of Design and Process FMEALead/facilitate review and disposition of discrepant materials identified for control of nonconforming productLead/perform product containment activities and arrange for dispositionSupport and generate continuous improvement ideas and work on cost reduction projects
Skills:First principles problem-solving skillsSelf-motivated, driven individual capable of working independently and in team settingsAbility to communicate technical information to both technical and non-technical stakeholders.Familiarity with GD&T, Good Manufacturing Practice (GMP) compliance and ISO complianceFamiliarity with clean room procedures and associated equipmentFamiliarity with 6-axis robots and motion controlled automated systemsAbility to create and interpret engineering drawings for mechanical and electrical systems
Qualifications:Bachelor’s Degree in Mechanical Engineering or with equivalent experience4+ years of experience in a technical quality role supporting design, manufacturing and NPIExcellent analytical skills; attention to detail, spreadsheet and database management skills; strong general computer skills