Qa/ra Sr. Executive

3 weeks ago

Faridabad, Haryana, India Kaapro Management Solutions Full time

Quality Assurance Administration training and auditing of Quality System Tools Customer Complaints CAPA Training Control Documents Standards Ensure compliance of quality procedures and work instructions with applicable standards Conduct audits training preventive and corrective actions to maintain the QA system Maintain training qualification and certification records of personnel Approve disapprove suppliers vendors facilities equipment processes and materials as per Quality Manual Regulatory Affairs Manage regulatory submissions in various countries Provide regulatory support across company functions Define and conduct tests bench tests for regulatory compliance Review and approve marketing social media and labeling materials Report directly to QA Director Experience Required Hands-on experience in Medical Devices with implementation of QMS Regulatory submissions as per ISO 13485 FDA CE MDD MDR and MEDDEV Drafting maintaining SOPs following GLP GMP requirements Experience in internal external audits inspections Preferred Skills ERP Priority and ALM Orcanos systems Strong English communication skills verbal written Independent self-motivated and proactive working style Strong planning organizational and interpersonal skills Technical knowledge and adaptability

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