Staff Internal Quality Auditor
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Job Summary
What you will do:
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
What you need:
Required:
Bachelors 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
Preferred:
Auditing experience in medical device or pharmaceutical industries
Required Experience:
Staff IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
