Related content
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
Position Summary:
The Supplier Quality Engineer serves as a key role for leading supplier quality controls activities and process improvement initiatives at Stryker sites. In this role, you will interface with many functions of the business and own the development and continuous improvement of global supplier quality controls systems, tools, policies, and procedures at assigned Stryker sites across the globe.
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.
• Partner 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.
• Work with site and divisional counterparts to own Corporate Purchasing Controls NC’s and CAPA’s (containment actions, root cause, corrective/preventive action, etc.).
What you need:
• 1+ years of experience in a manufacturing environment or equivalent
• Bachelor’s degree in engineering preferred.
• Experience in quality management systems.
• Supply Chain and/or Medical Device quality certifications or training.
• ISO 13485 Lead Auditor certification or equivalent.
• Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
• Experience supporting third-party inspection (FDA, Notified Body etc.) within the medical device industry.
Strong Skills communication Skills