Quality Engineer
Katalyst HealthCares & Life Sciences
Job-ID33117908Reference26-01846Summary:We are currently looking for Quality Engineers with experience in the medical device, pharmaceutical, biotechnology, or other regulated industries. The ideal candidate will have a strong understanding of quality systems, regulatory requirements, and manufacturing/validation processes.Roles & Responsibilities:Support quality activities related to manufacturing processes, products, and equipment.Review and maintain quality documentation, SOPs, work instructions, and quality records.Support CAPA, Client/deviations, root cause analysis, and corrective actions.Participate in process validation, equipment qualification, and change control activities.Support internal and external audits and ensure compliance with applicable regulatory requirements.Work with Engineering, Manufacturing, R&D, and Quality teams to identify and resolve quality issues.Ensure compliance with GMP/cGMP, FDA 21 CFR, ISO 13485, and other applicable standards.Assist with continuous improvement and maintain strong documentation and data integrity practices.Required Qualifications:Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field.0-2 years of experience in Quality Engineering/Quality Assurance.Experience in medical devices, pharma, biotech, or another regulated industry.Knowledge of CAPA, Client, deviations, change control, validation, audits, and quality systems.Strong communication, analytical, documentation, and problem-solving skills.
Vacancy posted 1 day ago
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