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Quality Specialist


Requisition Number: P10723

Region: US
State: Wisconsin
City: Menomonie

Responsibilities

  • Manage key quality processes (i.e., document control, non-conforming).
  • Support quality systems by collecting and providing information to internal and external customers and perform tasks such as generating engineering 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)
  • Interact with external customers on issues not requiring technical information from quality engineering such as customer approval/submissions, returned material authorization (RMA), etc.
  • Manage customized ERP activities such as generating and maintaining the doc control, NCMR and RMA/complaint systems
  • Effectively communicate Quality metrics across all levels of the organization
  • Maintain Device/Drug Master Record.
  • Gather, maintain and report facility quality metrics.
  • Complete incoming inspection of materials
  • Perform environmental monitoring on pre-established frequencies (and as needed)
  • Perform batch record review and release on completed production lots
  • Work within a team environment to complete other quality related duties as assigned
  • Some programs may have vision requirements
  • Other duties as assigned

Qualifications - Education & Experience

  • Technical Associates Degree in Quality related field with 0 – 2 years related experience
      OR
  • 1 – 2 years of directly related quality experience with no degree
  • Minimum two (2) years of experience in an engineering or customer-related discipline
  • At least one (1) year system management experience

Qualifications - Skills & Competencies

  • Strong organizational and time management skills
  • Proficient computer skills including ERP systems
  • High level of accuracy and attention to detail
  • Strong written, verbal and interpersonal communication skills
  • Understanding of quality systems 

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