QA/RA Sr. Executive

20 hours ago

Faridabad, Haryana, India Kaapro Management Solutions Full time ₹ 12,00,000 - ₹ 36,00,000 per year


Job Description:

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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