
QA/RA ive in medical devices
1 week ago
Urgent Hiring
We are looking to hire a QA/RA Sr. Executive for our organization with the following details:
Qualification: B.Sc. / M.Sc. (preferably with excellent knowledge of Medical Devices)
Experience: Relevant experience in QA/RA function within the Medical Device industry
CTC Salary Range: 35,000 –45,000/-PM
Location: IMT Faridabad Plant
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.
Kindly source and share suitable profiles at the earliest.
Best Regards
DC Tomar
Job Types: Full-time, Permanent
Pay: ₹35, ₹45,000.00 per month
Benefits:
- Health insurance
Education:
- Diploma (Preferred)
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