Job Description

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

:

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: ₹35,000.00 - ₹45,000.00 per month

Benefits:

Health insurance
Education:

* Diploma (Preferred)