The Quality Engineer will develop and maintain procedures, collaborate with teams on supplier quality controls, support audits, and track supplier performance metrics.
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.
- 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:
Required:
- B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Supplier quality.
- 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.
- Proficient in MS Office Suite (including Word, Excel, Power Point etc).
- Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
Preferred:
- Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive.
- Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
- Preferred German Language exposure.
- ISO 13485 Lead Auditor certification or equivalent
Travel Percentage: 10%
Top Skills
Eumdr
Fda
Iso 13485
Ms Office Suite
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