Quality Engineer in Los Angeles County

Job Summary

The Quality Engineer is responsible for quality planning and continuous improvement, working closely with production/operations and suppliers to reduce defects and improve product quality.  The Quality Engineer is responsible for process validations, failure mode and effects analysis, process control plans, work instructions, corrective and preventative actions. The Quality Engineer also supports product development and commercialization activities.

Essential Functions

• Develop, amend and implement standard GMP’s & SOP’s
• Develop and improve production processes
• Identify, prioritize and drive manufacturing and quality improvement projects
• Manage Material Review Board (MRB) for non-conforming products working with Manufacturing, Regulatory and Purchasing Departments for timely disposition
• Draft, review and execute equipment/process validations through IQ, OQ, PQ protocols
• Manage day-to-day quality concerns across process, products and service of manufacturing suppliers
• Understand quality control in supplier manufacturing operations
• Assess and monitors supplier performance to assure compliance with company standards.
• Review quality planning & control documents including; CAPA, FMEA, First Article, and participate in DFMEA development
• Collaborates with engineers and leadership to ensure quality and completeness of design history files, risk management, validation and change orders
• Conduct complaint investigations as needed
• Conducting tests and analysis to determine reasons for failures of procured materials, parts and/or processes using various testing methodologies and tools
• Initiate and investigate Corrective and Preventative Actions Plan as appropriate

Education/Experience Requirements

• Must Have Medical Device Experience
• BS in Engineering (Mechanical, Industrial or Biomedical)
• Minimum of 3+ years relevant experience gained in the medical device field  
• Experience in problem recognition and resolution on procured mechanical parts, materials, and assembly process issues
• Proven experience sustaining, improving and validating manufacturing processes and equipment associated with medical devices is required
• Thorough understanding of FDA QSRs including design controls and ISO 13485 requirements
• Experience in measurement analysis (gage R&R)
• Experience with 3D CAD software (Solidworks preferred)
• Experience in statistical analysis
• Experience in non-conforming product evaluation/disposition
• Self-motivated and able to work independently as well as in a team environment
• Must have demonstrated problem solving and troubleshooting skills
• Must have demonstrated verbal and written communication skills, and ability to effectively communicate with internal and external personnel