Staff Internal Quality Auditor

Jobtailor; Deutschland; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

Dormont Manufacturing Co is seeking a qualified Internal Audit Lead to independently guide audits of the Quality Management System (QMS). You will partner with site stakeholders to drive compliance, identify risks, and support continuous improvement.

Responsibilities include planning, executing, and reporting audits, documenting findings, and presenting insights to leadership. Fluency in English and Spanish is required; travel ~40% is expected.

Qualifikationen

• Bachelor’s degree or higher in a relevant field.
• Certified Lead Auditor is required.
• Minimum 2 years auditing experience in a regulated industry.
• Fluent in English and Spanish.
• Knowledge of FDA and ISO 13485 requirements.

Aufgaben

• 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 procedures.
• Document audit results, including nonconformances and observations.
• Present audit results to site leadership and stakeholders.
• Support execution of the Global Internal Audit Program.
• Monitor audit observations and elevate trends or systemic risks.
• Interface with Site RAQA and Quality leadership teams.

Kenntnisse

Attention to detail

Communication

Documentation

Ausbildung

Bachelor’s degree in engineering, science, business administration or related field

Certified Lead Auditor

Jobbeschreibung

Work Flexibility: Remote

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 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 13485 requirements

Preferred:

• Auditing experience in medical device or pharmaceutical industries

Travel Percentage: 40%