RA-QA Executive

Suhradam Apex Orthocure

Sanand, Ahmedabad

₹25,000 - ₹30,000 monthly

Fixed

₹25000 - ₹30000

Earning Potential

₹30,000

Work from Office

Full Time

Any experience

Good (Intermediate / Advanced) English

Job Details

Interview Details

Job highlights

29 applicants

Benefits include: Annual Bonus

Job Description

  • Implement and maintain the Quality Management System (QMS) as per ISO 13485 and company procedures.
  • Prepare, review, control, and update SOPs, procedures, manuals, and quality records.
  • Ensure compliance with GMP, GDP, and internal quality standards across departments.
  • Monitor process compliance and support continual improvement initiatives.
  • Prepare and maintain regulatory documentation for medical device registrations, renewals, and variations.
  • Coordinate with regulatory authorities and notified bodies as required.
  • Ensure compliance with applicable regulations (CDSCO, MDR, CE, or other applicable regulations).
  • Maintain product technical files, device master records (DMR), and regulatory dossiers.
  • Risk Management & Change Control
  • Support risk management activities as per ISO 14971.
  • Participate in change control, deviation handling, and impact assessment.
  • Ensure regulatory and quality compliance during product or process changes.
  • Non-Conformance, CAPA & Complaints
  • Handle deviations, non-conformances, and customer complaints.
  • Support root cause analysis and implementation of Corrective & Preventive Actions (CAPA).
  • Monitor CAPA effectiveness and maintain related records.
  • Plan, coordinate, and support internal, external, customer, and regulatory audits.
  • Ensure availability of quality and regulatory documents during audits.
  • Track audit observations and ensure timely closure.
  • Conduct and coordinate QMS and regulatory training for employees.
  • Coordinate with QC, Production, Purchase, Sales, and Marketing teams to ensure compliance.
  • Support supplier quality and regulatory compliance activities.

Job role

Work location

Changodar, Gujarat 382213, India

Department

Quality Assurance

Role / Category

Quality Assurance - Other

Employment type

Full Time

Shift

Day Shift

Job requirements

Experience

Any experience

Education

Graduate

English level

Good (Intermediate / Advanced) English

Gender

Any gender

About company

Name

Suhradam Apex Orthocure

Address

Changodar, Gujarat 382213, India

Job posted by Suhradam Apex Orthocure

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