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Quality Assurance Leader

Description

PHILLIPS-MEDISIZE, a Molex company, is hiring a 

Quality Assurance Leader 

location: Trhové Sviny, Jihočeský kraj, Česká republika


The main scope of this position is to support and sustain an effective and standardized Quality Assurance (QA) organization for the PMCZ Site. The position holder provides oversight to ensure that all activities in quality assurance areas for production and New Product Introduction are performed in a safe and compliant manner with focus on regulatory compliance and customer requirements. Ensures facility/divisional objectives are met and actively participates in continual improvement projects.


What You Will Do In Your Role

  • Plan for and implement an effective QA strategy through implementation of customer and ISO requirements 
  • Provide leadership to support the growth and development of the PMCZ QA organization, execute appraisal cycle for direct reports 
  • Effective QA team management to ensure all QA resources are planned according to demand of production and projects needs
  • Generate, review and authorize QA related documents 
  • Investigate Quality Notifications determining the root cause and implementing CAPA actions
  • Quality representative for PMCZ customers
  • Maintain effective internal audit program 
  • Ensure quality metrics are effective managed
  • Participate and support customer visits, programs, and all types of audits / inspections


The Experience You Will Bring

Requirements:

  • Good Manufacturing Practices 
  • 5+ years of professional experience (Quality)
  • Experience in Leading a Team  
  • Experience in production organization (Experience in a Pharmaceutical and/or Medical Devices company preferred) 
  • Experience with manufacturing processes like Injection Moulding, final assembly and packaging would be considered as a strong plus 


What Will Put You Ahead

  • Bachelor Level degree in Quality or a technical field or equivalent experience
  • Proven management and leadership capabilities
  • English language skills on level C1
  • Quality Management Systems (ISO13485 or FDA 21CFR820) 


We are an equal opportunity employer.

As part of Koch Industries, one of the largest private companies in the world, Phillips-Medisize is offering international career development within one of the leading global players in the drug delivery device and connected health space for innovation, development and manufacturing services and solutions.  

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