Key Responsibilities:
Ensure compliance with USFDA, GMP, and ISO 13485 requirements.
Maintain and review quality documentation and records.
Support CAPA, deviation, change control, and non-conformance management.
Assist in internal audits, regulatory inspections, and quality system activities.
Ensure adherence to SOPs and quality standards.
Requirements
Key Skills:
Knowledge of USFDA regulations and Quality Management Systems (QMS).
Documentation and record management.
CAPA, deviation handling, and root cause analysis.
Audit readiness and regulatory compliance.
Attention to detail and effective communication.
Skills Required
- 1-3 years of experience in the medical device or pharmaceutical industry
- B.Pharm, M.Pharm, B.Sc., or M.Sc. in a relevant discipline
- Knowledge of USFDA regulations and Quality Management Systems
- Experience with documentation and record management
- Knowledge of CAPA, deviation handling, and root cause analysis
- Audit readiness and regulatory compliance experience
- Attention to detail and effective communication
What We Do
Founded in 2006, Meril is an India-based global medical device company dedicated to innovating, designing, and manufacturing clinically relevant healthcare products. It develops vascular intervention, orthopaedic, diagnostics, endo-surgery, ENT, and robotic solutions, collaborating with physicians and global innovators to address unmet clinical needs. Through research, development, manufacturing, scientific communication, and distribution, Meril aims to alleviate human suffering and improve quality of life worldwide.
