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Senior Staff Engineer, Product Transfer / NPI Quality Engineering (2 Years Contract)

Oversee and approve validation documentation for global product transfers and relaunches
Skawina, Lesser Poland Voivodeship, Poland
Senior
yesterday
Stryker

Stryker

A global medical technology company specializing in orthopedic devices, surgical equipment, and neurotechnology products.

Product Transfer Quality Engineering

Location: Skawina, Poland

Time Type: Full Time

Work Flexibility: Hybrid

Product Transfer Quality Engineering function that enables successful transfers by driving quality, cost transformation and service improvements for our customers whilst remaining compliant to both internal and external standards. Will also work in the New Product Introduction (NPI) framework to oversee quality related activities for a product relaunch.

Will work within the QA Shared Services Product Transfer Team, responsible for quality related activities as it applies to Product Transfer, these include but not limited to the following:

  • Supporting all transfers globally, (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker)
  • Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as FMEA, MSAs, Validations and Qualifications.
  • Reviewing and approving of Validation/Qualification Documentation and assume the Validation Representative role.
  • Working with Validation Consultants/Contractors/Suppliers as required ensuring that Validations are completed as per corporate and divisional procedures.
  • Set PPAP requirements with suppliers and review and approve supplier PPAP documentation.
  • Point of contact for quality for product transfers at Scoping, Planning and Execution phases.
  • Enable successful completion of product transfer to achieve its quality, cost and time requirements.
  • Be able to identify PT quality risks/gaps and provide solutions to correct
  • Technical Quality Expert that sets quality strategy by utilizing a risk based approach around FAI's, Inspection Certification, leveraging etc.
  • Provide expertise for at least 2 quality speciality associated with product transfer
  • Product Transfer Independent Reviewer as required
  • Supports Product Transfer Process training where required
  • Provides feedback to lessons learnt for each completed product transfer
  • Drive continuous optimization of Product Transfer Process

Travel Percentage: 10%

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Senior Staff Engineer, Product Transfer / NPI Quality Engineering (2 Years Contract)
Skawina, Lesser Poland Voivodeship, Poland
Engineering
About Stryker
A global medical technology company specializing in orthopedic devices, surgical equipment, and neurotechnology products.