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Sr Engineer (CAPA)

Orange County Metro Area, CA

Posted: 04/29/2019 Job Type: Engineering Job Number: JN -042019-24789
Sr Engineer (CAPA)
Temp to Hire
Life Sciences Industry
Irvine, CA


Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and our Quality systems/procedures to optimize an effective Corrective and Preventive Action program.

Key Responsibilities:
  • Collaborate with CAPA owners on Investigation of nonconformance
  • Collaborate with CAPA owners and cross functional team to develop Investigation plan and adhere to CAPA phase timelines
  • Lead and assist with root cause analysis
  • Responsible for documentation and maintenance the CAPA file
  • Conduct Root Cause Analysis and CAPA process training
  • Continually assess the CAPA system and procedures for continual improvement
  • Perform other task, responsibilities as assigned
  • Other incidental duties assigned by Leadership
  • Proven expertise in usage of MS Office Suite
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
  • Working knowledge and understanding of statistical techniques
  • Substantial understanding and use of Root Cause Analysis tools
  • Substantial understanding of Investigation of Nonconformance
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Good leadership skills and ability to influence change
  • Knowledge of and adherence to Quality systems regulations
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Education and Experience:
  • Bachelor's Degree or equivalent in in Engineering or related field, 4 years experience working in a medical device, pharma, or other regulated industry
  • Master's Degree or equivalent in in Engineering or related field, 3 years experience related industry or industry/education experience Required
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