Deputy manager quality

2 weeks ago

Chandigarh, India Domnic Lewis International Full time

We are looking for a Deputy Manager Quality – South Asia & Middle East for a Global Medical Equipment Manufacturing MNC based in Chandigarh. Position: Deputy Manager Quality – South Asia & Middle East Qualification: Masters in life science + Certification in ISO 13485 auditing Experience: 5-10 years Location: Chandigarh-Punjab Job description: This position will work in collaboration with the Deputy Manager, Regulatory Affairs for South Asia & Middle East (SAME), the Director of Quality, Regulatory, Compliance, and Projects, as well as local Sales, Service Teams, and Distributors. The primary responsibilities of the role are focused on quality assurance, complaint handling, regulatory compliance, and ensuring efficient project management across various operational activities. Quality Assurance Responsibilities: Design, Implementation, and Maintenance of QMS: Design, implement, and maintain Quality Management policies and procedures to meet ISO 9001, ISO 13485, and other relevant standards, or as directed by senior management. System Integration and Monitoring: Monitor and integrate global management system SOPs and related documents into local systems, ensuring compliance with regional and global standards. Sales and Service Contracts: Ensure the quality management system incorporates requirements from Sales and Service contracts and ensure continuous compliance. Training and Staff Awareness: Ensure that all staff members are trained on their roles within the quality management system, and maintain training records for all impacted employees. Non-conformance Management: Efficiently manage non-conformances within the organization, ensuring that corrective actions are taken where necessary. Reporting: Compile and present monthly QRC (Quality, Regulatory, Compliance) reports to the Director of Quality, Regulatory, Compliance, and Projects. Provide management review reports as required for the Sales and Service Unit. Key Performance Indicators (KPIs) and Metrics: Identify, monitor, and report on quality metrics within review reports. Document and Data Control: Maintain document control systems to ensure proper documentation and data management. Supplier and Distributor Audits: Conduct quality audits for suppliers and distributors as needed. Complaints Handling Responsibilities: Complaint and Incident Management: Ensure that warranties, unplanned service incidents, product issues, business complaints, non-conformances, and CAPA (Corrective and Preventive Actions) are reported in accordance with local or global SOPs. KPI Monitoring: Ensure that complaints handling KPIs are met and actively monitored. General Responsibilities: Regulatory Affairs Support: Provide backup support to the Deputy Manager, Regulatory Affairs, in areas related to regulatory compliance and post-market activities. Compliance Issue Identification: Discuss emerging or potential compliance issues with management and employees. Industry Trends and Best Practices: Stay informed about changes in the industry, trends, and best practices, and assess their potential impact on organizational processes. Process Improvement: Design and implement improvements in the communication, monitoring, and enforcement of compliance standards. Project Monitoring: Oversee projects to ensure that objectives, success criteria, quality, and time frames are achieved. Manage project risks and take appropriate actions to reduce risk. Customer Relationship Management: Maintain strong relationships with existing customers by ensuring compliance with contract requirements, obtaining feedback, and ensuring quality service. Required Skills and Qualifications: In-depth Knowledge of Standards: Extensive knowledge of ISO 9001 and ISO 13485 as they pertain to the Medical Device Industry, along with a strong understanding of health and safety regulations and risk management. Auditor Qualifications: Certification in ISO 13485 auditing. Risk Management Expertise: Ability to apply current risk management standards, principles, and frameworks. Communication Skills: Strong verbal and written communication skills. Self-management: Ability to work with minimal supervision, meet agreed-upon deadlines, and prioritize tasks effectively to achieve desired results. Technical Proficiency: Proficiency in Microsoft Office Suite (Word, Power Point, Teams, Excel) and other relevant tools. Cross-functional Teamwork: Ability to collaborate effectively with local, regional, and global teams, and demonstrate strong teamwork. Training Experience: Experience in developing and delivering training programs. Complaint Handling Expertise: Experience with complaint handling processes and practices. Legislation Knowledge: Familiarity with relevant legislation and the ability to acquire knowledge of pertinent codes and practices. Regulatory Affairs Expertise: Knowledge of regulatory affairs within South Asia and the Middle East, with an understanding of applicable regulatory requirements. Relevant candidates can reach out to

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