KH
Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
2 weeks ago
- CAPA
- GMP
2 weeks ago
Not enough detail in this posting to match
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.
- 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.
Quality Engineer · Katalyst Healthcares & Life Sciences