Complete risk-based audits of suppliers per Stryker’s required cycle times to ensure conformance and compliance of suppliers and manufacturing partners in Europe.
The role is responsible for the coordination and implementation of on-site and documentation audits, related observations, Non-Conformities, CAPAs and communication of evaluation results to key stakeholders as well as driving timely closure of NCs through the CAPA system.
Provide cross-functional supplier auditing services to Stryker’s R&D, Acquisition, Manufacturing, Materials, Purchasing, and Operations stakeholders worldwide.
Partnering with cross-functional component suppliers, contract manufactures, and original equipment manufacturers to drive process improvements of the quality systems.
Act as a technical liaison between suppliers, Engineering, Purchasing, and Manufacturing, to support projects and to resolve supplier quality issues.
Ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations.
Supply information into the metrics, trends, and performance indicators of suppliers in order to drive continuous improvement throughout the supply chain.
Provide input into the supplier performance information and selection of new suppliers for the Stryker Global Approved Supplier List.
Serve as a subject matter expert for supplier evaluations, share expertise within the site.
Root cause analysis of processes related manufacturing defects and warranty concern
Train and educate suppliers on GMP, regulatory requirements, and Stryker expectations as well as foster strong relationships with Stryker’s supplier-partners acting as an extended enterprise.
Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection.
Drive continuous improvement actions within supplier processes by identifying and communicating ineffective or inefficient Quality Management System processes.
The top three performance objectives for this role are: (1) drive continuous improvement within the Stryker supply base, (2) ensure compliance and conformance, and (3) ensure effective and efficient Quality Management Systems are established, documented, implemented, and maintained.
What are we looking for?
Degree in engineering, or engineering related discipline required
3 to 5 years of relevant experience in Quality, Management, or Engineering
Experience conducting supplier audits and internal audits preferred, ISO-13485 Lead Auditor certification or equivalent preferred
Demonstrated collaboration, negotiation, and conflict resolution skills, high level of empathy
Critical thinking and strong analytical skills, comprehends production/process controls, FDA verification/validation, problem solving and root cause
Excellent time management and organization skills, with high emphasis on attention to detail
Strong communication skills across various functions and levels
Must be able to work independently; motivated to perform at a high-level without supervision
Be a strategic partner to the business, understand and communicate how the Quality role impacts the business processes
Fluent in English, ideally fluent in another European language
Travel is approximately 60%, regular travel to supplier facilities required, must be able to travel internationally
Work From Home: YesTravel Percentage: Up to 75%Jetzt bewerbenJetzt bewerbenNoch nicht für eine Bewerbung bereit?
