Website:
careessentials.com.au
Job details:
Company Description
Care Essentials International Pvt Ltd, a subsidiary of Care Essentials Pty Ltd, based in Australia, has been a leader in temperature management solutions since 1996. The company is renowned for its innovative Cocoon Convective Patient Warming System, which includes a comprehensive range of quality Cocoon blankets exported globally. Care Essentials is committed to excellence and delivering top-tier products that meet industry standards for patient care worldwide.
Role Description
This is a full-time, on-site position for a QA Manager - Medical Device at Care Essentials International Pvt Ltd, located in Ahmedabad. The QA Manager will be responsible for overseeing quality assurance processes, ensuring compliance with regulatory standards for medical devices, conducting audits, managing quality documentation, and driving continuous improvement initiatives. Additional responsibilities include leading a team, coordinating with cross-functional departments, and addressing quality-related issues to maintain the company’s high-quality product standards.
Qualifications
- Experience with Quality Assurance processes, Quality Control, and compliance in a medical device manufacturing environment
- Knowledge of regulatory standards such as ISO 13485 and FDA requirements
- Proven ability in conducting internal and external quality audits
- Strong skills in documentation, reporting, and change control management
- Proficiency in team leadership, problem-solving, and project management
- Excellent communication skills and the ability to collaborate with cross-functional teams
- Understanding of production processes in medical device manufacturing is advantageous
- Bachelor’s degree in Engineering, Quality Management, or a related field; relevant certifications like Six Sigma or ASQ Certified Quality Engineer (CQE) are a plus
Education
- Bachelor's degree (preferably B Tech) with 3-8 years of experience in Medical Device
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