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Quality Specialist


Requisition Number: P11842

Region: US
State: Wisconsin
City: Eau Claire

Responsibilities

  • Support
    quality systems by collecting and providing information to internal and
    external customers and perform tasks such as generating document change
    orders, ensuring quality system paperwork is up-to-date and meets GMP
    compliance
  • Support quality during audits and visits (i.e., customer, regulatory, registrar, internal), as required.
  • Interact
    with external customers on issues not requiring technical information
    from quality engineering such as corrective actions, customer
    approval/submissions, returned material authorization (RMA), etc.
  • Manage customized ERP activities such as generating and maintaining GMP, doc control, , NCMR and RMA/complaint systems
  • Effectively communicate Quality metrics across all levels of the organization
  • Manage key quality processes (i.e., deviation, OOS, document control, release activities, etc).
  • Assist with the requirements of AQP and corresponding documentation per quality system standards
  • Redline and submit documents through change order system
  • Review packets for release:
  • -Analyze SPC data in accordance with the control plan and customer specific requirements.
  • -Complete C of C
  • -Scan/physically move product, as appropriate.
  • -Review data for GDP errors.
  • -Work with personnel to correct GDP errors.
  • Manage GDP tracking and facilitate continuous improvements based on data.
  • Work within a team environment to complete other quality related duties as assigned

Qualifications - Education & Experience

  • 1 – 2  years of directly related quality experience
  • Minimum two (2) years of experience in an engineering or customer-related quality role
  • At least one (1) year system management experience
  • Proficient computer skills including ERP systems
  • Strong organizational and time management skills
  • Ability to meet timelines.
  • Understanding of quality systems and metrology

Qualifications - Skills & Competencies

  • Strong organizational and time management skills
  • High level of accuracy and attention to detail
  • Strong written, verbal and interpersonal communication skills

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