Sr Quality Engineer in Los Angeles, CA at Apex Life Sciences

Date Posted: 9/26/2018

Job Snapshot

Job Description


Responsibilities:

  • Supporting Manufacturing through implementation of improved Production and Process Controls
  • Managing projects using Problem Solving and Statistical Tools while keeping to Predefined Deadlines
  • Maintaining Risk Management Documents for Released Product (includes Risk Managements Plans/Reports, Risk Analysis Documents, Risk Management Files, dFMEA and pFMEA)
  • Providing support with review and execution of Process and Test Method Validations
  • Providing support to manufacturing line, nonconconformances and dispositions 
  • Support manufacturing line with possible coverage of second shift and weekends.
  • Performs other related duties as assigned

Basic Qualifications:

  • Bachelor of Science Degree in Engineering or Science-related field and 4 years work experience in Quality Assurance or Quality Engineering OR Master of Science Degree in Engineering or Science-related field and 5+ years’ work experience in Quality Assurance or Quality Engineering 
  • Work experience in medical device in a manufacturing environment with production and controls. 


Desired/Preferred Qualifications: 

  • 8+ years’ work experience in Quality Assurance and/or Quality Engineering in a regulated environment 
  • Experience in FDA 21 CFR Part 820 FDA Quality System Regulation, ISO 14971 risk management and other relevant international standards 
  • Certified Lean or Six Sigma Black Belt 
  • Project Management experience 
  • Experience working with remote suppliers and facilities, both domestic and international 
  • Chemistry experience. 
  • An ability to interact with personnel on significant technical matters often requiring coordination between organizations 
  • Working knowledge of problem solving and statistical methods as applied to process and product quality 
  • Proficiency in MS Office, including Word, Excel, Outlook, and PowerPoint 
  • Strong English verbal and written communication and presentation skills 
  • Self-Starter and accountable, with sharp focus on quality and customer experience 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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