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Engineering Specialist - Quality

Requisition Number: P12303

Region: US
State: Wisconsin
City: New Richmond


  • 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 approvals/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
  • Safety/Environmental:
       - Where applicable, individual is pre-planning safety into work activities to improve performance
       - Proactively identifies safety concerns
       - Complies with Environmental Management System program SOP’s/WI, Policy & Program elements and encourages responsible use of resources
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction

Qualifications - Education & Experience

  • Technical associates degree; or equivalent mix of education and experience
  • Minimum two (2) years’ experience in an engineering or customer-related discipline at a plastic injection molder
  • At least one (1) year project management experience
  • Manufacturing Experience

Qualifications - Skills & Competencies

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

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