Senior Quality Engineer

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Location
Greater Los Angeles, CA
Salary
$110,000 - $125,000
Job Type
Direct Hire
Date
Jan 04, 2018
Job ID
2555745
We are seeking an experienced Senior Quality Engineer for the Operations Quality Engineering team.
 
Job Duties:
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Support stability studies per drug/device combination product regulations
  • Lead, coach, and mentor non-exempt and entry level exempt personnel
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Design and conduct experiments for process optimization and/or improvement
  • Appropriately document experiment plans and results, including protocol writing and reports
  • Lead process control and monitoring of CTQ parameters and specifications
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Lead the investigation, resolution and prevention of product and process non-conformances
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead in the completion and maintenance of risk analysis
  • Work with design engineering in the completion of product verification and validation
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
 
Qualifications:
  • BS degree in Engineering or Technical Field or equivalent experience
  • 5+ years’ experience, 2+ of which should consist of drug or combination product experience
  • Engineering experience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
  • Solid communication and interpersonal skills
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
 
Preferred Qualifications:
  • Advanced degree preferred
  • Demonstrated supervisory experience preferred
 
GR Identifier: $Medd, $Neer