Job Description
- 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.
Job Description
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Job Tags
Contract work, Immediate start,