Senior Internal Quality Auditor

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

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.

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• 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.

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

• Minimum of 2+ years medical device or regulated industry experience
• Quality Audit experience (internal, external, and/or supplier) required
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2003, 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

• Computer literacy.
• Some travel may be required.
• Ability to multitask and work in international time zones.