Supplier Quality Controls Engineer

3 tygodni temu

Warszawa, Mazovia, Polska Stryker Corporation Pełny etat

Supplier Quality Controls Engineer

Apply locations Warsaw, Poland time type Full time posted on Posted Yesterday job requisition id R537085 Work Flexibility: Hybrid

What you will do
  1. Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls.
  2. Partner with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs.
  3. Support tracking and reporting of KPI and other metrics associated with supplier performance. Articulate detailed supplier performance results and trends to appropriate levels of management.
  4. Support Third Party inspection (FDA, Notified Body etc.) and Stryker Corporate audits of the quality system.
  5. Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA).
  6. Provide best in class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
  7. Contribute to initiatives for improvement and implementation of processes, to build a best in-class Supplier Quality Controls organization.
  8. Work with site and divisional counterparts to own Corporate Purchasing Controls NC's and CAPA's (containment actions, root cause, corrective/preventive action, etc.).
What you need
  1. Bachelor's degree in a science, engineering or related discipline preferred, or equivalent years of experience.
  2. 2 + years of experience in manufacturing environment or equivalent.
Preferred Qualifications:
  1. Experience in quality management systems.
  2. Supply Chain and/or Medical Device quality certifications or training.
  3. ISO 13485 Lead Auditor certification or equivalent.
  4. Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
  5. Ability to effectively communicate information to team members, leaders, management, and suppliers.
  6. Experience supporting third-party inspection (FDA, Notified Body etc.) within the medical device industry.

Travel Percentage: 10%

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