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Quality Systems Specialist I (3rd Shift)

Company: Cepheid
Location: Lodi
Posted on: January 6, 2022

Job Description:

  • Review records and documents for completeness and compliance with QSR and ISO requirements.
  • Create Certificate of Conformances for each lot released.
  • Review the QC measurement data and upload the data and Certificate of Conformance into an on-line database for each lot.
  • Create and apply approval labels for release products.
  • Coordinate with the Shipping Department the shipping of release parts to the production facilities.
  • Perform material movement and release transactions in the company s ERP system.
  • Create and Maintain inventory of retains samples that are stored offsite.
  • Assist with corrective action activities in the resolution of issues.
  • Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
  • Participate in interdepartmental initiatives for continuous improvement.
  • Generate standard operating procedures to define and improve quality system functions.
  • Support QS Manager to implement and monitor Manufacturing and Quality Systems procedure.
  • Review records and documents, for completeness and compliance with QSR and ISO requirements.
  • Support the eDMS electronic documentation process as needed.Education and Experience (in years):
    • High school diploma with at least 2 years of work experience in a manufacturing environment.
    • Must be familiar with ISO standards and applicable regulatory requirements (CE/FDA/QSR)REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)
      • Excellent verbal and written communication skills in group or one-on-one settings.
      • Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems.
      • Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
      • Understanding of general mathematical principles and calculations, at college entry level.
      • Experience in compiling data to support metrics analyzing current process.
      • Understanding root cause analysis, failure analysis and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting.
      • Detailed and quality oriented.
      • Strong organizational skills.TRAINING RESPONSIBILITIES: (REQUIRED)
        • Complete all assigned and required training satisfactorily and on timePREFERRED QUALIFICATIONS (optional):
          • Experience in DNA diagnostics or other medical devices
          • Associate s degree a plus but not required.PHYSICAL DEMANDS
            • Ability to work in an office environment
            • Maintain flexibility in work schedule as interface with personnel on 2nd and weekends shifts are required.
            • Frequent walking between locationsWhen you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.If you ve ever wondered what s within you, there s no better time to find out. Associated topics: attorney, attorney corporate, business, company, compliance department, compliance office, corporate attorney, lawyer, legal department, llp

Keywords: Cepheid, Lodi , Quality Systems Specialist I (3rd Shift), Other , Lodi, California

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