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Senior Quality Engineer

  • LocationValencia, CA 91355 - United States
  • Work TypeFull time
  • Positions1 Position
  • Job no: 42332
  • Category: Quality

Sr. Quality Engineer - Alfred Mann Foundation Valencia, CA Position summary: The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to monitor and improve quality efforts. Develop risk analysis documents as required to support development and manufacturing decisions. Design and implement process and facility validation programs. Coordinate and maintain the nonconformance and corrective/preventative action programs. Analyze quality data including reporting to supervision. Promote quality assurance, and quality control policies and activities in partnership with key technical groups to ensure product quality and regulatory compliance. Must have a good working knowledge of CFR 820, ISO 14971 and ISO 13485. Main responsibilities: • Understand the corporate objective • Perform Root Cause analysis and implement corrective and preventative measures to improve product quality • Initiate and lead project teams on CAPA, NCR and Failure Analysis investigations • Maintain CAPA, NCR and Failure Analysis databases • Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failures • Work closely with R&D, Manufacturing and QC to produce products that meet specifications and perform as designed • Define, develop, and improve manufacturing processes and quality standards • Assist in the transfer of newly developed products from R&D to Manufacturing • Writing and executing test plans, analyzing data and creating test reports • Support Clinical team with customer complaints including product issues • Support design engineering team with development of receiving inspection procedures, acceptance criteria, and sampling plans in accordance with industry standards as required • Lead MRB to determine and resolve issues with received material • Maintain quality system, manufacturing, calibration, inspection, and maintenance procedures as required • Perform validations of processes, equipment, and test methods as required • Perform internal and supplier qualification audits as required. This includes, but is not limited to, preparation of audit plans, audit reports, and verifying corrective actions have been completed and are effective. • Perform additional duties as assigned by supervisor Education/Experience: • Bachelor’s degree in engineering (EE preferred) or a related field and/or a combination of > 5 years practical and educational experience in the medical device industry is required • Fluent with Excel spreadsheets • Reading engineering drawings (e.g. SolidWorks®, AutoCAD®, etc.) • Must have excellent written and verbal communication skills • Good understanding of CFR 820 and ISO 13485:2016 • Methodical approach to problem solving • Self-motivated organized team player with high ethical standards