Work Flexibility: Hybrid

What you will do

• Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls.
• Partner with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs.
• 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.
• Support Third Party inspection (FDA, Notified Body etc.) and Stryker Corporate audits of the quality system.
• Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA)
• Provide best in class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
• Contribute to initiatives for improvement and implementation of processes, to build a best in-class Supplier Quality Controls organization.
• 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

• Bachelor’s degree in a science, engineering or related discipline preferred, or equivalent years of experience.
• 2 + years of experience in manufacturing environment or equivalent

Preferred Qualifications:
• Experience in quality management systems.
• Supply Chain and/or Medical Device quality certifications or training.
• ISO 13485 Lead Auditor certification or equivalent.
• Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
• Ability to effectively communicate information to team members, leaders, management, and suppliers.
• Experience supporting third-party inspection (FDA, Notified Body etc.) within the medical device industry.

Travel Percentage: 10%