Quality Assurance Compliance Specialist

About the Role As a Quality Assurance Compliance Specialist, you will serve as a critical guardian of operational excellence, ensuring that our manufacturing processes consistently meet rigorous industry standards. You will drive continuous improvement by identifying process gaps and mentoring teams on quality system requirements to ensure long-term compliance and product integrity. Responsibilities Execute comprehensive internal audits, gathering objective evidence to validate adherence to established quality protocols. Facilitate the audit lifecycle, from defining scope and setting agendas to leading closing meetings with plant leadership. Document and categorize audit findings, ensuring clear communication of conformities and non-conformities to drive corrective actions. Author and distribute detailed audit reports to stakeholders, providing actionable insights for upper management. Provide strategic guidance to manufacturing sites during external audits, assisting in everything from initial planning to complex problem-solving. Oversee the execution of layered process audits and product-specific inspections to maintain high-quality output. Assist operational teams in drafting and submitting formal responses to external audit findings. Foster a culture of quality by coaching personnel on regulatory requirements and best practices. Qualifications Required Skills Proven experience in quality auditing within a manufacturing environment. Deep understanding of

ISO 9001

standards and certification processes. Strong analytical skills with the ability to interpret complex technical documentation. Excellent verbal and written communication skills for reporting findings to diverse audiences. Preferred Skills Experience with root cause analysis and corrective action (CAPA) methodologies. Previous involvement in supporting third-party or registrar audits. Certification in Quality Auditing (CQA) or similar professional designation.