Experience: 0–3 Years
Industry: Medical Devices Manufacturing
Employment Type: Full-Time
About the Role
We are looking for a motivated and detail-oriented Medical Device Quality Assurance (QA) Executive to join our quality team. This position is ideal for candidates who have a basic understanding of quality systems and regulatory requirements and are interested in building a career in the medical device industry.
The selected candidate will support quality assurance activities including documentation review, gap analysis, validation support, CAPA tracking, internal audits, and compliance-related activities. Comprehensive training will be provided on company procedures, quality management systems, and applicable regulatory requirements.
Key Responsibilities
- Assist in maintaining and improving the Quality Management System (QMS).
- Support gap analysis activities against applicable standards, regulations, and internal procedures.
- Participate in validation and qualification activities, including documentation review and execution support.
- Assist in preparation, review, and control of quality documents, SOPs, work instructions, and forms.
- Support Corrective and Preventive Action (CAPA) processes and follow-up activities.
- Help maintain document control and record management systems.
- Participate in internal quality audits and compliance assessments.
- Assist with complaint handling, non-conformance investigations, and root cause analysis.
- Support risk management and change control activities.
- Coordinate with cross-functional teams to ensure compliance with quality requirements.
- Assist in supplier quality and quality monitoring activities as required.
- Prepare reports, metrics, and quality-related documentation.
Required Qualifications
- Diploma or Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, or a related field.
- Basic understanding of Quality Assurance principles.
- Knowledge of documentation practices and quality systems.
- Good written and verbal communication skills.
- Strong attention to detail and organizational skills.
- Ability to learn and work in a regulated environment.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Preferred Knowledge
Candidates with basic exposure to any of the following areas will be preferred:
- Quality Management Systems (QMS)
- Medical device regulations
- Gap analysis methodology
- Validation and qualification concepts
- CAPA processes
- Internal auditing
- Risk management
- Change control
- Document control
- Non-conformance management
- Root cause analysis tools
- ISO 13485 awareness
- Good Documentation Practices (GDP)
- Regulatory compliance concepts
Pay: From ₹20,000.00 per month
Benefits:
- Flexible schedule
- Paid sick time
- Paid time off
Work Location: Hybrid remote in Changodar, Ahmedabad, Gujarat
