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