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Sr. Engineer Quality
Ref No.: 18-04193
Location: Irvine, California
Position Type:Right to Hire
Start Date / End Date: 10/15/2018 to 04/15/2019
Position Description:
  • Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Quality systems/procedures to optimize an effective Corrective and Preventive Action program.  Please refer to the job description for additional details.
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.
Qualification:
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. 
Additional Skills:
• 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