Senior Internal Quality Auditor

Work Flexibility: Hybrid or Onsite

This is a permanent hybrid role with full Stryker benefits and 40% travel.

What you will do:

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.

• Lead Internal audits from planning, execution, closure, reporting, and post-audit follow-up with minimal oversite
• 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.

What you will need:

• Bachelor’s degree or equivalent experience required
• Minimum of 2+ years medical device or regulated industry experience 
• Lead Auditor Certification Required
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), and other national and international regulations.  
• Excellent communication skills at all levels, both written and verbal (English)  
• Performs in a professional manner and represents the group in a way that is collaborative and promotes a positive image while building effective relationships with customers and stakeholders  
• Solid knowledge of manufacturing processes, statistical techniques, validation, sterilization, environmental controls and basic Regulatory requirements for medical devices 

  

 

Ireland Pay Ranges:

• Ireland: €49,000 - €82,000 EUR Annual

  

 

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role.  In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

 

If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

  

 

Travel Percentage: 40%