Quality Assurance Executive

About US

Madhu Instruments Pvt. Ltd. (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors.

Responsibilities

• Device Master File Compliance
• Draft the Device Master File to align with Indian Medical Device Rule 2017 requirements, ensuring full compliance for regulatory submissions and audits.
• Clinical Data Collection and Compilation
• Collect and compile data related to device safety and performance from scientific journals and databases, including EMBASE, PubMed, and Cochrane, to support regulatory submissions and product evaluations.
• Technical Documentation and Regulatory Compliance
• Assist in drafting technical documents, including Biological Evaluations, Risk Management, and Usability Reports, in compliance with EUMDR 2017/745 regulations.
• Prepare and manage technical files for certification audits to meet EUMDR 2017/745 standards, ensuring that all documentation is thorough and accurate.
• Quality Management System (QMS) Compliance
• Ensure thorough understanding and implementation of QMS standards as per ISO 13485:2016 and Annexure IX of EUMDR 2017/745.
• Maintain and update all QMS documentation, including manuals, procedures, and policies, to ensure ongoing compliance with quality standards.
• Quality Documentation Management
• Create, update, and manage company quality documentation, ensuring that manuals, procedures, and records are maintained accurately.
• Monitor and enforce consistent implementation of quality management systems across the organization.
• Audit Management
• Coordinate internal and external audits, including those conducted by notified bodies, focusing on QMS and CE marking.
• Address any non-conformance reports promptly and efficiently, working toward continuous improvement.
• Customer Complaint and Incident Management

Qualifications

• Education:

   Bachelor’s degree in a relevant scientific or engineering field, preferably with a focus on medical devices.

• Experience:

   2-5years in QA for medical device manufacturing, with in-depth knowledge of relevant regulations and standards.

• Technical Skills:

• Proficiency in regulatory requirements (Indian Medical Device Rule 2017, EUMDR 2017/745, ISO 13485:2016).
• Expertise in data sourcing from EMBASE, PubMed, and Cochrane, with strong data compilation skills for clinical evaluations.

• Soft Skills:

• Strong written and verbal communication skills.
• Excellent organizational skills and attention to detail.