Manufacturing Quality Engineer

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Responsibilities:

• Analyses defects and manage Non-Conformances (Company) and Quality Notifications (QNs).
• Implement effective Corrective and Preventive Actions (CAPAs).
• Support PFMEA assessments and design transfer activities.
• Monitor operations performance, assist in risk assessments and continuous improvement.
• Coordinate quality engineering tasks in support of New Product Introduction (NPI).
• Utilize advanced statistical analysis for data trend interpretation.
• Conduct process validation and support regulatory compliance efforts.
• Collaborate with suppliers, R&D, and manufacturing teams to resolve quality issues.

Requirements:

• Bachelor's degree in mechanical engineering, Electronics Engineering, Science, or equivalent; Vocational Education accepted with additional experience.
• None required with a bachelor's degree.
• OR 4+ years of experience with Vocational Education.
• Process Quality Management.
• Root Cause Analysis (RCA).
• CAPA methodologies.
• Regulatory knowledge.
• Data analysis, DFQ, and technical documentation.
• Risk assessments and process monitoring.

All your information will be kept confidential according to EEO guidelines.