Quality Engineer - Supplier Controls

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