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Senior Supply Chain Quality Manager
1 tydzień temu
About Us
Stryker Group is a world leader in providing innovative medical technology solutions. Our commitment to quality and patient care drives us to create products that make a meaningful difference in people's lives.
Your Role
We are seeking a skilled Global Supplier Quality Senior Engineer to lead our supplier quality controls efforts globally. In this role, you will work closely with cross-functional teams to develop and implement quality systems, tools, policies, and procedures.
Main Responsibilities:
- Develop and Implement Quality Systems: Develop, revise, maintain, and inactivate local site procedures to ensure alignment with corporate guidelines for purchasing controls.
- Collaborate with Stakeholders: Collaborate with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs.
- Monitor and Report Performance: Support tracking and reporting of KPIs and other metrics associated with supplier performance. Provide detailed supplier performance results and trends to management levels.
- Audit and Compliance: Support Third Party inspection (FDA, Notified Body) and Stryker Corporate audits of the quality system. Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA).
- Support Business Partners: Provide best-in-class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
- Local Initiatives and Projects: Support local initiatives and projects for improvement, and implement processes to build a best-in-class Supplier Quality Controls organization.
- Corporate Purchasing Controls: Work with site and divisional counterparts to own Corporate Purchasing Controls NC's and CAPA's.
Requirements
To be successful in this role, you should have a strong background in Supply Management, Quality, or Engineering within a regulated industry, preferably in the medical device industry. You should also possess excellent communication skills to relay technical information to both internal teams and external stakeholders.
Preferred Qualifications:
- Experience in quality management systems.
- Supply Chain and/or Medical Device quality certifications or related training.
- ISO 13485 Lead Auditor certification or equivalent.
- Knowledge of ISO 13485, FDA, EUMDR, and regional medical device regulatory requirements.
