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HIHilo by Aktiia

Sr. Quality Engineer - Manufacturing(m/w/x)

Neuenburg
Full-timeWith Home OfficeSenior
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Quality engineering for continuous blood pressure monitor manufacturing with contract partners. ISO and FDA QSR knowledge required. Flexible work location, hybrid schedule, occasional international travel.

Requirements

  • Bachelor's degree in technical or scientific field
  • 5-8 years experience in quality or manufacturing
  • Team leadership skills
  • Independent project prioritization, execution, and reporting
  • Knowledge of ISO and FDA/Quality System Requirements
  • Strong project management skills
  • Strong time management skills
  • Familiarity with Risk Management per ISO 14971
  • Creative problem solving for complex issues
  • Effective problem solving for complex issues
  • Ability to work on multiple tasks concurrently
  • Ability to manage changing priorities
  • Proficiency with MS Teams
  • Proficiency with MS Word
  • Proficiency with MS Excel
  • Proficiency with MS PowerPoint
  • Proficiency with AI tools
  • Proficiency with eQMS systems
  • Bachelor's Degree
  • Mid-Senior level experience

Tasks

  • Lead quality engineering activities with contract manufacturers
  • Support IQ, OQ, PQ processes and non-conformance resolution
  • Conduct process and test method validations
  • Resolve manufacturing non-conformances with contract manufacturers
  • Approve DHRs, DHF deliverables, product releases, and change orders
  • Coach manufacturing personnel and contract manufacturers on GMP and QMS
  • Lead cross-functional teams to resolve quality issues
  • Navigate the CAPA process
  • Drive product improvement and operational efficiency projects
  • Support internal labeling reviews for required markings and symbols
  • Lead supplier management activities for contract manufacturers
  • Conduct supplier audits, qualifications, and assessments
  • Support QMS audits with internal and external auditors

Work Experience

  • 5 - 8 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • MS Teams
  • MS Word
  • MS Excel
  • MS PowerPoint
  • AI tools
  • eQMS systems
  • ISO 13485
  • ISO 14971
  • FDA 21 CFR Part 820
  • MDR
  • FMEA

Benefits

Flexible Working

  • Flexible work location
  • Hybrid work schedule

Other Benefits

  • Occasional international travel
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Hilo by Aktiia and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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