Department: Quality Assurance / Engineering
Location: Chandigarh
Experience: 5 to 8 years
Reports To: Director of the company
Job Summary:
We are looking for a dedicated and technically skilled Quality Head with 5 to 8 years of experience in the healthcare equipment industry. The ideal candidate must have hands-on experience with ventilators, patient monitors, and other critical care hospital equipment. This role involves performing stringent quality inspections and ensuring that all medical devices meet regulatory, functional, and safety standards before reaching healthcare facilities.
Key Responsibilities:
- Perform quality inspections and functional tests on ventilators, patient monitors, syringe pumps, and other medical devices.
- Ensure all equipment adheres to industry standards such as ISO 13485, IEC 60601, and BIS compliance.
- Document quality inspection findings and maintain accurate QC records and test reports.
- Identify and report non-conformities and collaborate with production and service teams to resolve issues.
- Conduct periodic equipment calibration, testing, and validation.
- Ensure labeling, packaging, and documentation align with medical device compliance protocols.
- Support internal audits and assist during external regulatory inspections.
- Suggest improvements for testing procedures and product quality.
Required Skills and Qualifications:
- Diploma or Degree in Biomedical Engineering, Electronics, or related technical field.
- Minimum 5 years to maximum 8 years of relevant experience in quality checking or service of medical devices.
- Good knowledge of hospital equipment, especially ventilators and patient monitors.
- Understanding of medical equipment standards, safety procedures, and quality systems.
- Skilled in using electrical and mechanical testing tools.
- Strong attention to detail, documentation skills, and problem-solving mindset.
Preferred:
- Prior experience working in a medical device manufacturing company.
- Certification in Medical Device Quality Systems (optional but advantageous).
- Familiarity with Government e-Marketplace (GeM) compliance and hospital tenders is a plus.