QA/RA Manager

Job Title: QA/RA Officer

Location: Noida

Job Type: Full-time

Salary: 40-45 K

Job Summary:

We are looking for a skilled QA/RA Officer with 3 to 5 years of experience in Quality Assurance within the medical device industry to ensure our products meet regulatory standards and quality requirements. The role involves developing and maintaining technical documentation for regulatory submissions, preparing key files such as Device Master Files, Design History Files, and Risk Management Files, and overseeing the CAPA process. You will also conduct internal audits, identify non-conformities, and support external audits to ensure compliance with ISO 13485, ISO 14971, and other relevant standards. Strong analytical, problem-solving, and communication skills are essential, as is the ability to collaborate with cross-functional teams to ensure continuous improvements in product quality and regulatory compliance.

Key Responsibilities:

• Develop and maintain technical documentation for regulatory submissions.
• Prepare, review, and implement Standard Operating Procedures (SOPs) and relevant formats.
• Oversee the Corrective and Preventive Action (CAPA) process to ensure compliance.
• Conduct internal audits, identify non-conformities, and drive corrective actions.
• Ensure compliance with global regulatory requirements for medical devices.
• Support external regulatory audits and inspections.
• Collaborate with cross-functional teams to enhance product quality and regulatory compliance.

Requirements & Qualifications:

• Bachelor's degree (Biomedical Engineering or a related field).
• Required Experience 3 to 5 years in Quality Assurance within the medical device industry.
• Required Knowledge & Skills:
• Regulatory Standards & Compliance:

o ISO 13485 – Quality Management Systems for Medical Devices

o ISO 14971 – Risk Management for Medical Devices

o ISO 62366 – Usability Engineering for Medical Devices

o Indian Medical Device Rules (IMDR) 2017

o Audit Planning & Management for Class B & C Medical Devices

• Documentation & Technical Writing:

o Quality Management System (QMS) Documentation

o Device Master File (DMF) Preparation

o Site Master File (SMF) Preparation

o Design History File (DHF) Preparation (ISO 13485)

o Risk Management File (ISO 14971)

o Usability Engineering Report (ISO 62366)

Job Type: Full-time

Pay: ₹400,000.00 - ₹500,000.00 per year

Benefits:

• Provident Fund

Schedule:

• Morning shift

Ability to commute/relocate:

• Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Medical: 3 years (Preferred)

Work Location: In person

Application Deadline: 02/08/2025
Expected Start Date: 25/07/2025