Staff Internal Quality Auditor

Stryker

Quality Auditor responsible for leading internal audits of QMS and ensuring compliance within regulated industries. Collaborating with site stakeholders to enhance quality and risk management.

Posted 7/22/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading internal audits to ensure compliance with FDA and ISO 13485 standards, while effectively communicating audit results and insights to leadership. Proficient in risk identification and continuous improvement within Quality Management Systems.

Highest-signal resume keywords

Certified Lead AuditorInternal AuditingFDA ComplianceISO 13485 KnowledgeBilingual in English and Spanish

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System (QMS)Audit PlanningRisk AssessmentNonconformance DocumentationAudit Reporting

Soft Skills

CollaborationCommunicationProblem-Solving

Certifications & Qualifications

Certified Lead Auditor

Industry Keywords

Regulated IndustryMDR/MDD ComplianceContinuous ImprovementAudit Program Execution

About the role

Key responsibilities & impact

Responsible for independently leading internal audits to assess compliance and effectiveness of the Quality Management System (QMS).
Partners with site stakeholders to drive compliance, identify risks, and support continuous improvement.
Lead internal audits from planning through execution, reporting, and follow-up
Develop and tailor audit scope, agenda, and plans based on site inputs
Assess compliance to FDA, ISO 13485, MDR/MDD, and company procedures
Document audit results, including nonconformances and observations
Present audit results and insights to site leadership
Support execution of the Global Internal Audit Program
Monitor audit observations and escalate trends or systemic risks
Interface with Site RAQA and Quality leadership teams

Requirements

What you’ll need

Bachelor’s degree in engineering, science, business administration or related field.
Certified Lead Auditor (or equivalent quality auditing certification) required
At least 2 years of experience auditing in a regulated industry
Fluent in both English and Spanish required
Working knowledge of FDA and ISO 13485 requirements

Benefits

Comp & perks

Work Flexibility: Remote