Quality Engineer - Supplier Controls
Quality Engineer - Supplier Controls
Posted on :
11-04-2025
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1 Vacancy
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Job Description
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 inclass Supplier Quality Controls organization.
- Work with site and divisional counterparts to own Corporate Purchasing Controls NCs and CAPAs (containment actions root cause corrective/preventive action etc..
- Additional duties as assigned.
What you need:
Required:
- B.Tech (Electronics/Electrical/Mechanical) with 25 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 thirdparty 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 crossfunctional teams (engineering R&D manufacturing regulatory affairs).
Preferred:
- Understanding of Medical Device Regulatory Compliance (ISO 13485 CFR 820 or comparable standard / regulation) and EUs 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
Employment Type
Full-Time
Key Skills
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