KALEIDOSCOPE INNOVATION PRODUCT DESIGN
Published
05/22/2019
Location
Cincinnati
Job Type
Contact Name
Brittany Vennemeyer
Street Address
4362 Creek Road

Description

SUMMARY

Our Quality team manages the compliance of the company to ISO 13485:2016, including executing and maintaining internal design controls and assisting in client-lead design controls. We develop process improvements, and new procedures, policies, and templates; developing and maintaining company training and training records. Our team leads CAPAs and complaints to appropriate closure.

Kaleidoscope is looking to hire a Quality Assurance Engineer to expand our Quality team, increasing the amount and value of impact Quality and the Quality Management System has on the company.

PRINCIPAL DUTIES & RESPONSIBILITIES

  • Complete system improvements
  • Generate updates to existing procedures, policies, and templates
  • Assist project teams is Design Control execution
  • Participate in Audits, Quality led training, and Management Review
  • Address audit findings
  • Complete, or assist with, CAPA corrective and preventive actions

QUALIFICATIONS

  • Associate’s or Bachelor’s degree in Engineering or related field
  • 1-3 years of experience preferred
  • Experience in medical device development preferred
  • High attention to detail in striving for excellence in processes, deliverables and execution
  • Maintains rational and objective demeanor/actions when faced with stressful and/or emotional situations
  • Manages competing demands and balancing multiple priorities while ensuring deadlines are met
  • Strong inclination for continuous improvement
  • Works well independently as well as collaboratively with colleagues and clients
  • Demonstrated ability to write and prepare documents/reports/correspondence in a concise, logical, grammatically appropriate format
  • Demonstrated ability to handle sensitive information with discretion and tact
  • Proficient with Microsoft Office applications: (Word, Excel, PowerPoint, Access, Outlook)


 EEO/M/F/Disabled/Vet

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