Quality Engineer (Manufacturing)

Job Summary:
We are seeking a Quality Engineer with a strong background in manufacturing and experience in one or more of the following areas: Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, or Good Documentation Practices (GDP) / Good Manufacturing Practices (GMP). The Quality Engineer will play a crucial role in ensuring product quality, compliance with regulatory standards, and continuous improvement of manufacturing processes.

Responsibilities:

• Quality Systems & Compliance:
• Ensure compliance with GMP, GDP, ISO 9001, ISO 13485, or other relevant industry standards in manufacturing processes.
• Support and lead Deviation investigations, ensuring timely root cause analysis and implementation of corrective actions.
• Manage and contribute to the CAPA process, ensuring proper identification, documentation, and resolution of non-conformities.
• Assist in Change Control processes, evaluating potential impacts and ensuring proper risk assessment and implementation.
• Manufacturing Support & Continuous Improvement:
• Work closely with manufacturing, production, and operations teams to identify quality issues and drive process improvements.
• Support the implementation of Lean, Six Sigma, or other continuous improvement initiatives to enhance product quality and process efficiency.
• Conduct risk assessments (e.g., FMEA) and collaborate with cross-functional teams to implement preventive actions.
• Audits & Documentation:
• Assist with internal and external audits by regulatory agencies and customers, ensuring proper documentation and compliance.
• Maintain and improve Good Documentation Practices (GDP) to ensure accuracy and traceability of records.
• Prepare and review quality reports, including trend analysis, investigations, and quality metrics.
• Training & Communication:
• Provide training to manufacturing and quality teams on quality standards, procedures, and best practices.
• Collaborate with cross-functional teams to ensure effective communication of quality-related concerns and initiatives.