Supplier Quality Senior Engineer serves as a key role for leading Supplier Quality Controls activities and process improvement initiatives at Stryker sites. In this role, you will interface with many functions of the business and own the development and continuous improvement of Global Supplier Quality Controls systems, tools, policies, and procedures at assigned Stryker sites across the globe.
The Supplier Quality Senior Engineer focuses on developing processes that build quality into the products we sell and driving a culture of continuous improvement to support Stryker's mission & strategic goals.
Additional responsibilities include: Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls.Collaborate 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.Support local initiatives and projects 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.).Additional duties, as assigned.What you need Education / Work Experience Basic Qualifications: Bachelor's degree in a science, engineering or related discipline preferred, or equivalent years of experience.2+ years of experience in Supply Management, Quality, and/or Engineering, in a regulated industry.Preferred Qualifications: Bachelor's degree in engineering preferred.Experience in quality management systems is desired.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.
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