Senior Internal Quality Auditor - Lead Global Audits Hybrid

Stryker; Cork; Hybrid; EUR 49,000 - 82,000; Full time

Benefits offered by this job

40% travel

Job summary

Stryker is seeking a qualified Internal Audit professional to lead audits across global sites. The role emphasizes collaboration with GQO and site stakeholders, interpretation of FDA/ISO/MDD requirements, and reporting of findings to drive quality improvements.

The position requires a strong regulatory background, excellent communication, and the ability to operate in a highly regulated environment with 40% travel. Hybrid or onsite work available in Ireland.

Qualifications

• Bachelor’s degree or equivalent experience.
• Minimum of 2+ years medical device or regulated industry experience.
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42 EEC).
• Excellent communication skills at all levels, both written and verbal (English).
• Solid knowledge of manufacturing processes, statistical techniques, validation, sterilization, environmental controls and basic regulatory requirements for medical devices.

Responsibilities

• 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 from the site.
• Interpret and provide guidance on applicable regulations (FDA, ISO, MDD).
• Assist in coordinating the Internal Audit program to ensure compliance to quality system requirements.
• Present audit results and data to site stakeholders.
• Escalate emerging trends of audit findings to identify areas for improvement.
• Interface with Site RAQA Heads and GQO Management where applicable.
• Monitor observations from external and Corporate quality audits.

Skills

Audit planning

Regulatory knowledge

Communication

Audit reporting

Stakeholder collaboration

Education

Bachelor’s degree or equivalent

Tools

Lead Auditor Certification

Job description

Stryker is seeking a qualified Internal Audit professional to lead audits across global sites. The role emphasizes collaboration with GQO and site stakeholders, interpretation of FDA/ISO/MDD requirements, and reporting of findings to drive quality improvements.

The position requires a strong regulatory background, excellent communication, and the ability to operate in a highly regulated environment with 40% travel. Hybrid or onsite work available in Ireland.