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Open nowFirst seen 27 hours ago

Quality Engineer

Human Power BG383 open roles

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Your applicationOpen nowQuality EngineerHuman Power BG

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  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: first seen 27 hours ago

The posting

Human Power is a company that provides consulting and recruitment for the best companies in Bulgaria.

For one of our partners, we are currently looking for a Quality Engineer.

Position Overview

  • The Manufacturing Quality Engineer is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all products and processes with a focus on manufacturing activities in the plant.

Primary Duties and Responsibilities:

  • Provide Quality Engineering support in the development and manufacturing of new and existing disposable medical devices.
  • Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
  • Monitor & analyze production information to support risk management and lead corrective/preventative actions (CAPA)
  • Support process validation of manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Plan and evaluate process conformance and perform quality audits for various business processes.
  • Monitor projects, identify risks and issues and prepare documents for same.
  • Train various teams for quality procedures and ensure compliance to best practices.
  • Design statistical sampling process, review finish products and perform audit on same.
  • Represent Quality Assurance on Engineering Change Orders and Material Review Boards for manufacturing and supply chain.

Job Qualifications:

  • Engineering, Electrical or Electronic Engineering is advantage
  • 2+ years of experience in QA/QE in the medical device or automotive field
  • Understanding of ISO 9001, IATF 16949. FDA regulations and ISO13485 are advantages
  • Experience with formal problem-solving methodologies and deductive skills
  • Experience with handling non-conforming material and assemblies, including root cause investigations
  • Use of statistical data analysis; ideally Six Sigma methods & tools
  • Experience with SAP or other ERP system is a plus

If you are interested and meet the above requirements, please submit your CV.

We appreciate your interest!

Only short-listed candidates will be contacted and invited for an interview in a timely manner.

Candidates won’t be charged for any services provided. ***

All applications will be treated in strict confidentiality. All the information is protected by the Commission for the Protection of Personal Data. *** Human Power holds Unlimited License №3084 providing human resources services.

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