Job Description
Job DescriptionSummary:
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.