Quality Assurance Regulatory Affairs Manager- Equipments
3 weeks ago
Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on project status.·Boundary less involvement in new organizational initiatives
Quality Assurance:·Capture & improve in-process yield metrics·Final goods performance yield tracking & sustenance·Implement non-conforming material process & resolve rework, scrap or return tovendor·Understand parts, processes and performance·Implement engineering change management·Perform regular IQA·Face the quality audits and CAPA process·Streamline incoming parts quality & track metrics.·Boundary less involvement in new organizational initiatives.
Documentation and Reporting:·Ensure all regulatory submissions, reports, and records are accurate, complete,and maintained according to company and regulatory standards.·Develop and maintain technical files, dossiers, and other regulatory documentsfor all products.·Prepare and present quality and regulatory reports to management.
Qualifications:·Bachelor’s degree in a scientific, engineering, or related field. Advanced degreepreferred.·8-12 years of experience in Quality Assurance and/or Regulatory Affairs in(relevant industry, e.g., pharmaceuticals, medical devices).·Thorough knowledge of relevant regulatory guidelines (e.g., FDA, EMA, ISOstandards).·Experience with regulatory submissions and interactions with regulatory bodies.·Strong organizational skills, with attention to detail and the ability to managemultiple projects simultaneously.·Excellent communication and interpersonal skills, with the ability to workeffectively in cross-functional teams.
Preferred Skills:·Certification in Regulatory Affairs (RAC) or Quality Assurance.·Experience with electronic quality management systems (eQMS).·Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
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Madurai, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly...
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madurai, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...
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Madurai, India Aurolab Full timeKEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...
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Madurai, India Aurolab Full timeKEY RESPONSIBILITIES:Regulatory Affairs:·Build the technical files and drive risk management.·Understand parts, processes and performance.·Implement engineering change management.·Perform regular IQA.·Work closely with all cross-functional team members.·Review design documents & participate in periodic design reviews.·A weekly operating mechanism on...
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madurai, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...
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Madurai, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...
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Madurai, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly...
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Madurai, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...
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Madurai Palace, India Aurolab Full timeKEY RESPONSIBILITIES: Regulatory Affairs: ·Build the technical files and drive risk management. ·Understand parts, processes and performance. ·Implement engineering change management. ·Perform regular IQA. ·Work closely with all cross-functional team members. ·Review design documents & participate in periodic design reviews. ·A weekly operating...
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Madurai, India Aurolab Full timeAs a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...
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Madurai, India Aurolab Full timeAs a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...
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Madurai, India Aurolab Full timeAs a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...
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madurai, India Aurolab Full timeAs a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the...
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