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 *****, MDR/MDD, and company procedures.
Document audit results, including nonconformances and observations.
Present audit results and insights to site leadership.
Support execution of the Integral Internal Audit Program.
Monitor audit observations and elevate trends or systemic risks.
Interface with Site RAQA and Quality leadership teams.
What you need:
Required:
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 ***** requirements.
Preferred:
Auditing experience in medical device or pharmaceutical industries.
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