Quality Assurance / QC/ QA/ ( ISO 15485) CDSO ( Medical Devices)

Location:

Position:

Experience Required:

Salary:

Industry:

Certification:

Job Summary:

Quality Assurance Executive

Key Roles & Responsibilities:

Quality Assurance & ISO Documentation

• Ensure

  implementation and maintenance

  of ISO 13485:2016 QMS.
• Prepare and maintain

  SOPs, DHR, DMR, CAPA, NCR, internal audit reports

  .
• Conduct internal audits and coordinate external audits (ISO, CDSCO).

Regulatory Compliance (CDSCO)

• Prepare and manage technical documentation as per CDSCO regulatory requirements.
• Assist in device registration and licensing.
• Maintain compliance with Indian medical device rules and documentation control.

Quality Control / Product Testing

• Perform

  in-process and final quality inspections

  of medical devices and instruments.
• Implement quality check protocols and record results.
• Identify defects, initiate corrective actions, and support production improvements.

PCB Soldering & Inspection

• Perform

  manual inspection and quality checks

  on PCB boards and electronic assemblies.
• Understand and inspect

  soldering quality, component mounting, and connectivity

  .

Reporting & Continuous Improvement

• Generate QA reports and recommend process improvements.
• Coordinate with design, R&D, and production teams for quality assurance integration.
• Support in product development and validation from a quality perspective.

Key Skills & Competencies:

• Strong knowledge of

  ISO 13485:2016

• Familiarity with

  CDSCO regulations

  for medical devices
• Experience in

  QA/QC processes

  for electronic and medical instruments

• Good documentation skills

  and attention to detail
• Hands-on with

  PCB inspection and soldering

Qualifications:

• Diploma / B.Tech / B.Sc in Electronics, Biomedical, or equivalent
• Certification in ISO or Regulatory Affairs (preferred)