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Quality Specialist


Requisition Number: P11842

Region: US
State: Wisconsin
City: Eau Claire

Responsibilities

 

  • 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 CHR 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.
  • 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
  • Work within a team environment to complete other quality related duties as assigned
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
  • Completion of one of the following:

- Submission of a continuous improvement idea
- Active participation in a Phillips-Medisize sponsored committee or event

Qualifications - Education & Experience

  • 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
  • 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
  • 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 and metrology

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