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
