Staff Internal Quality Auditor - Cork, Carrigtwohill IDA Business & Technology Park Tullagreen

Work Flexibility: Hybrid

Position Summary

The person in this position is responsible for working collaboratively with key stakeholders from new and existing Global Quality and Operations (GQO) Stryker sites in the planning, execution and reporting of Internal Audits. It is critical for this person to quickly build strong relationship throughout Stryker’s global footprint. This individual must possess very strong written and oral communication skills and be able to report findings throughout all levels of the organization in a collaborative and fact-based manner that is conducive to building strong partnerships. A keen understanding of the highly regulated environment, great attention to detail, and the ability to make important decisions independently are requirements of the position. 

Essential Duties & Responsibilities: (Detailed Description)

• Lead Internal audits independently from planning, execution, closure, reporting, and post-audit follow-up 
• Plan and tailor the audit agenda and scope based on feedback and information received from the site being audited
• Interpret and provide guidance on applicable regulations such as FDA, ISO, MDD and Stryker policies  
• Assist in the coordination of Stryker Internal Audit program to ensure compliance to quality system requirements  
• Present audit results and correlating data to key stakeholders at the site location
• Escalate emerging trends of audit findings to identify areas for improvement 
• Interface with Site RAQA Heads, GQO Quality Management and International RAQA Management, where applicable
• Monitor observations from external and Corporate quality audits of Stryker sites

Education & Special Trainings:

• Bachelor’s degree or equivalent experience required
• Professional certification in Quality Auditing (i.e. Certified Lead Auditor) required

Qualifications & Experience:

• Minimum of 4+ years medical device or regulated industry experience 

• Minimum of 2+ years Quality Audit experience (internal, external, and/or supplier)  

• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), and other national and international regulations.  

Travel Percentage: 30%