Lead Internal Quality Auditor — Global Ops (Hybrid)

Stryker Corporation; Cork; Hybrid; Confidential; Full time

Benefits offered by this job

Hybrid work model

Stryker benefits package

Job summary

Stryker in Cork, Ireland, seeks a Senior Internal Quality Auditor to partner with GQO sites worldwide, leading planning, execution, and reporting of internal audits with strong stakeholder collaboration. Requires Lead Auditor Certification and 2+ years in a regulated medical-device environment, plus excellent written and spoken English.

Expect 40% travel and a hybrid/onsite schedule with comprehensive benefits; you will interpret FDA/ISO regulations and drive continuous improvements across the

Qualifications

• Lead Auditor Certification required.
• Minimum 2+ years in medical device or regulated industry.
• Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, and Medical Device Directive (93/42/EEC).
• Excellent written and verbal communication at all levels.

Responsibilities

• Lead internal audits from planning to post-audit follow-up.
• Plan and tailor audit agendas based on feedback from audited sites.
• Interpret and provide guidance on applicable regulations (FDA, ISO, MDD).
• Present audit results to site stakeholders and correlate data.
• Escalate emerging trends to identify areas for improvement.

Skills

Lead Auditor Certification

Regulatory knowledge

Communication skills

Quality systems

Education

Bachelor’s degree or equivalent

Job description

Stryker in Cork, Ireland, seeks a Senior Internal Quality Auditor to partner with GQO sites worldwide, leading planning, execution, and reporting of internal audits with strong stakeholder collaboration. Requires Lead Auditor Certification and 2+ years in a regulated medical-device environment, plus excellent written and spoken English.

Expect 40% travel and a hybrid/onsite schedule with comprehensive benefits; you will interpret FDA/ISO regulations and drive continuous improvements across the