Stability Specialist (Tatabánya)

Stability Specialist (Tatabánya)
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Partnerünk részére keresünk tapasztalattal rendelkező szakembert a következő pozícióba:

Stability Specialist

Feladatok

  • Create stability protocols for existing products and to make new protocols and studies as a result of design changes;
  • Coordinating Stability Tests;
  • Tracking the utilization of optimization climate chamber;
  • Updates/changes to the DMR content;
  • Update/create process RA and ensure all risks are mitigated;
  • Update Quality and Control plans in case of changes to Product RA, DIO, specifications and test methods;
  • Update process RA due to changes to Product RA and DIO;
  • Need for repeating validations in case of changes to DIO and/or Product RA;
  • When established during MDR this might give additional requirements to process validation which might not have been covered in the initial validation;
  • Additionally, Severity and Probability scorings might change due to update of DIO and PRA);
  • Need for facilitating screening activities to support specification setting if missing spec for older products;
  • Take out samples for design verification and organise testing of samples with production/QA lab;
  • Support test method validation activities to ensure compliance with current test method procedures;
  • Provide/create information for the manufacturing flowcharts for regulatory purposes.

Elvárások

  • Scientific academic background: E.g. MSc Engineering, or similar;
  • Fluent in both spoken and written English;
  • Knowledge of relevant regulatory and quality standards in Medical Device area;
  • IT skills: Microsoft Office and statistical software (for example sas.jmp).

Amit kínálunk

  • Work-life balance
  • Stabil background

Előnyök

  • College / university degree, preferred Quality ;
  • Some level of experience in documentation and reporting;
  • Knowledge of quality and technical issues;
  • Experience in ISO 9001, ISO 13485;
  • Knowledge to MS Project is preferred.

Munkavégzés helye

  • Tatabánya

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Hire-One Személyzeti Tanácsadó Kft. Nyilvántartási szám: 3376-1/2008.

Tatabánya

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