QA /RA MANAGER( in Medical devices)

3 weeks ago

Ballabgarh, India Dhruv Enterprises Full time

Urgent Hiring

We are looking to hire a QA/RA Manager 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: 70000 – 80000/-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: ₹70, ₹80,000.00 per month

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