Global Supplier Quality Manager
2 tygodni temu
Job Description:
Stryker Group is seeking a skilled Supplier Quality Controls Engineer to join our team. As a key member of our organization, you will be responsible for leading Supplier Quality Controls activities and process improvement initiatives at Stryker sites globally.
Key Responsibilities:
- Develop, revise, maintain, and inactivate local Stryker site procedures ensuring alignment with 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.
- Track and report KPIs and other metrics associated with supplier performance, articulating detailed supplier performance results and trends to management.
- 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).
- Provide best-in-class support to business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
- Support local initiatives and projects for improvement, implementing 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.
Requirements:
- Bachelor's degree in a Science, Engineering, or related discipline preferred.
- 1+ years of experience in Supply Management, Quality, or Engineering within a regulated industry (medical device industry preferred).
- Fluency in English.
Preferred Qualifications:
- Experience in quality management systems is desired.
- 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.
- Strong communication skills with the ability to relay technical information to internal teams and external stakeholders.
- Experience in supporting third-party inspection (FDA, Notified Body) within the medical device industry.
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