Customer Quality Engineer (m/f/d)

  • Skopje 1000, Skopje 1000, North Macedonia
  • Full-time

Company Description

Gerresheimer is a leading global partner to the pharma and healthcare industry. Since its foundation in Germany in 1864, the publicly traded company now operates worldwide with 10,000 employees and generates revenue of €1,4 billion. Gerresheimer’s product portfolio includes pharmaceutical packaging and products for the safe and simple administration of medicines, i.e. insulin pens, inhalers, pre-fillable syringes, injection vials, with manufacturing facilities in Asia, Europe and North-and South America.
Gerresheimer will build and establish a new facility in Skopje, North Macedonia as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry.

Job Description

  • Quality support for a defined product spectrum over the entire product life cycle both internally and to the customer
  • KPI responsibilty: CRIT (complaint response in time in own area of ​​responsibility), CAPA overdue (in own area of ​​responsibility) 
  • Customer support for quality-related topics
  • Customer complaints handling
  • Participation in the handling of internal deviations
  • Editing change requests
  • Risk management
  • Audit participation
  • Targeted and trusting cooperation with internal and external interfaces (e.g. production areas, plant management and in particular the customer)
  • Independent compliance with standards, legal regulations (e.g. labor law, occupational safety regulations) as well as internal regulations
  • Responsibility for product-related documentation (PMF / DMR, partly DHF and DMF)
  • Update quality-related production specifications (inspection plans, defect catalogs, acceptance criteria, inspection level, etc.), adapt to requirements and reflect regularly

Qualifications

  • Minimum of 3 years’ experience in Quality management in a manufacturing facility. Preferable to have injection molding plastic experience or medical device and / or pharmaceutical packaging products experience
  • Bachelor degree or above, preferable to major in Scientific, Engineering or related field
  • Macedonian: business fluent (required), English fluent (required), German skills would be an advantage
  • Profound knowledge of SPC and SQC applications in a manufacturing environment
  • Further IT skills in e.g. MES, SAP, MS Office
  • Expertise in a clean room environment would be an advantage
  • Strong communication skills both internally and externally utilizing networking and exchanging best practices
  • Possesses intercultural sensitivity and understanding, with the ability to work collaboratively an international business environment
  • Willingness to international business travel within the first month of the employment as onboarding will be mainly in our facilities in Germany for around three month
  • Employment will be with our company in the Republic of North Macedonia
  • Reporting line to the Head of Plant Quality of the Skopje plant

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