Trwa ładowanie. Prosimy o chwilę cierpliwości.
Stryker
Data aktualizacji: 2024-07-17
Skawina, małopolskie
BPO/SSC, Project Management
angielski
Praca stacjonarna, Praca hybrydowa
Data aktualizacji: 2024-07-17 Aplikuj
Quality Validation Engineer

Quality Validation Engineer

Skawina

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

RESPONSIBILITY:

What you will do as Staff Engineer Validation includes:

  • Is actively involved in the development of Stryker's validation strategy, consisting of the Corporate Validation Procedure and the related work instructions.
  • Supports the definition of validation strategies for highly complex validation projects (multiple entities or multiple sites).
  • Review/Approval of relevant validation deliverables, as required, as Validation Representative.
  • Maintains and delivers training modules for the training of the Corporate Validation Procedure, the related work instructions and ValGenesis.
  • Drives due diligence activities related to validation.
  • Coordinates Validation Certification of Engineers.
  • Supports internal, corporate, and external audit, if required.
  • Acts as Subject Matter Expert for at least two special validation skillsets (e.g. Computer System Validation (CSV) / Qualification of Buildings, Facilities and Utilities (BFU) / Analytical Test Methods (ATM)).
  • Leads at least one Corporate Validation SME group in the global Validation Hub
  • Spoke team to improve and develop Stryker's validation program.
  • Acts as local Site Administrator in Stryker's electronic Validation Lifecycle Management System (eVLMS) ValGenesis for several sites.
  • Contributes to the development of ValGenesis.
  • Act as coach for junior team members.

QUALIFICATIONS:

  • Bachelor of Science, Engineering, or related subject with 6 years of experience in validation.
  • Medical devices experience.
  • Experience working in highly regulated manufacturing industry.
  • Must be fluent in Polish and English
  • Excellent communication skills

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.