ALAN Electronic Systems - Medical
Location
Thane | India
Job description
Job Description:
Position: Management Representative Department: Compliance Location: Ambernath, Maharashtra Responsibilities: 1. Establish, implement, and maintain all processes necessary for the Quality Management System (QMS) to ensure compliance with regulatory standards. 2. Regularly report to top management on the performance of the Quality Management System and provide insights on areas for improvement. 3. Foster awareness of regulations throughout the organization to ensure alignment with quality objectives. 4. Obtain and maintain mandatory regulatory accreditations, including ISO 13485, ISO 9001, MDR 2017/745 (EU), MDR-2017 (INDIA) etc. and others as applicable as and when required. 5. Independently oversee and manage all aspects of external compliance audits, including coordinating with auditors, preparing necessary documentation, addressing any audit findings, and ensuring compliance with regulatory requirements and standards 6. Document all company policies, procedures, and work instructions clearly, concisely, and comprehensively according to the regulatory requirements as applicable. 7. Ensure comprehension of the Quality Policy among all employees and promote adherence to it. 8. Plan and execute periodic internal audits in accordance with regulatory and organizational requirements. 9. Organize and facilitate Management Review Meetings (MRM), including preparation of agenda, recording input and output, and ensuring follow-up on action items. 10. Provide adequate training to all company personnel on documented company policies, procedures, and regulatory requirements. 11. Prepare and submit MRM reports to top management for review and decision-making. 12. Preparation, Review and finalization of all essential documents to obtain regulatory accreditations in coordination with relevant cross-functional depts. 13. Maintain confidentiality of all critical documents and records that impact business operations. Qualification Criteria: ●Bachelor's / Master’s degree in a preferred field such as- Engineering, (e.g., Mechanical Engineering, Electrical Engineering, Biomedical Engineering), B.Sc, M.Sc. ●Minimum of 10 years of experience in a quality management role, preferably in a regulated industry such as medical devices. ●Strong understanding of quality management principles and standards, including ISO 13485, ISO 9001, MDR 2017/745 (EU), MDR-2017 (INDIA) and other relevant regulations and certifications. ●Experience in establishing, implementing, obtaining and maintaining mandatory regulatory accreditations, including ISO 13485, ISO 9001, MDR 2017/745 (EU), MDR-2017 (INDIA) etc. and others as applicable.Job tags
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