Senior 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:

• Evaluate and improve contract manufacturers' processes through research, design, and collaboration.
• Develop and optimize manufacturing processes and equipment in partnership with vendors.
• Onboard and manage contract manufacturers, ensuring regulatory compliance.
• Enhance manufacturing efficiency through workflow and layout analysis.
• Design and implement testing methods to ensure product and process quality.
• Serve as a key resource for manufacturing and quality-related inquiries.
• Ensure compliance with regulatory standards to maintain product reputation.
• Support design and development projects, including training contract manufacturers.
• Maintain quality engineering functions such as supplier controls, audits, and validations.
• Participate in Material Review Board and CAPA processes to address non-conformances.
• Provide design control support for new product development, including risk management.
• Drive continuous improvement of the Quality Management System (QMS).
• Conduct internal and supplier quality audits.
• Create and maintain documentation for product specifications, validations, and design history files.
• Support QMS functions such as document control, training, and device history record management.

Requirements:

• Bachelor's degree in engineering or a related technical field, or equivalent experience.
• 6-8 years of experience in manufacturing and supplier quality engineering.
• Experience with process validations and contract manufacturer management.
• Background in medical devices and FDA-regulated industries.
• Strong knowledge of ISO 13485 standards.
• Excellent communication, organizational, and project management skills.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong analytical and problem-solving abilities with a proactive mindset.

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