Quality Control Engineer
7 dni temu
This is a key role for leading Supplier Quality Controls activities and process improvement initiatives at Stryker sites. The successful candidate will interface with various functions of the business, owning the development and continuous improvement of Global Supplier Quality Controls systems, tools, policies, and procedures at assigned Stryker sites across the globe.
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.
- Support tracking and reporting of KPI and other metrics associated with supplier performance, articulating detailed supplier performance results and trends to appropriate levels of management.
- 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.
To be successful in this role, you will need:
- Bachelor's degree in a Science, Engineering or related discipline preferred.
- 3+ years of experience in Supply Management, Quality, or Engineering within a regulated industry (medical device industry preferred).
- Fluent spoken and written English and German.
- 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 both internal teams and external stakeholders.
- Experience in supporting third-party inspection (FDA, Notified Body) within the medical device industry.
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