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Quality Assurance Coordinator

Company: hireneXus
Location: Petaluma
Posted on: June 18, 2022

Job Description:

(Hybrid Opportunity) Job Purpose: The primary duty of a Quality Assurance Coordinator is to maintain and continuously improve the effectiveness of the Quality Management System in support of the Company Quality Policy. This included establishing, implementing, and maintaining processes necessary for the QMS. Is also responsible to ensure that the QMS is in conformance with appropriate regulatory standards and requirements throughout the organization, as such the Quality Coordinator interacts with a number of Compnay operations, including Sales, Engineering, Customer Service, Marketing, Production, and Human Resources. This position is directly related with several quality-related processes, as outlined below. This role requires a high degree of initiative and self-motivation. Responsibilities: include, but are not limited to the following:

  • Review the management of CAPA (Including follow-up and assurance that the objective evidence of efficacy is captured)
  • Review and management of the customer feedback and complaint process
  • Review and management of the Risk Management Process
  • Review and assess manufacturing procedures
  • Identify Quality Issues
  • Execution of Internal Audits
  • Execution of Functional Testing
  • Maintain Awareness of regulatory changes and notify appropriate personnel of make necessary changes to maintain compliance
  • Develop and distribute professional and formal response to customer-reported quality problems
  • Seek and exploit opportunities to improve the QMS
  • Maintains current knowledge of government and industry compliance standards
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance
  • Technical writer
  • Develops and maintains auditing schedules.
  • Performs other duties as assigned by the Quality Manger
  • Communicates between customer and Senior management Job Requirements: Job Qualifications/Requirements:
    • Bachelor's degree (B.S.) in related field or equivalent preferred
    • Four to six years related experience or equivalent preferred
    • Strong knowledge of manufacturing processes, computer and equipment validation, GMPs, and product/process validation,ISO 9001 , ISO 13485:2016 and 21 CFR Part 820
    • Knowledge and experience with REACH, RoHS, ECHA, & UKCA
    • Knowledge and experience with UDI labeling
    • Knowledge and experience in Statistical in evaluation and analysis of data.
    • QC Inspection Techniques
    • Thorough knowledge of FDA regulations.
    • Interpret complex laws, regulations, and/or policies.
    • Experience in research and development
    • PPAP experience (DFMEA, PFMEA, Control Plan, GR &R, SPC)
    • Commitment to excellence and high standards
    • Strong organizational, problem-solving, and analytical skills
    • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
    • Acute attention to detail
    • Working knowledge of data collection, data analysis, evaluation, and scientific method.
    • Ability to develop clear, concise, and timely oral and written reports.
    • Accurately complete detailed forms and reports.
    • Analyze complex data and information
    • Good understanding of Microsoft Office applications
    • Excellent written and oral communication skills
    • Fluent in English language is preferred
    • 6 sigma or Black Belt a plus. - -

Keywords: hireneXus, Petaluma , Quality Assurance Coordinator, Other , Petaluma, California

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