Quality Management System Documentation / QMS Auditor

EC International Certification; Pune District; On-site; INR 800,000 - 1,400,000; Full time

Job summary

EC International Certification in Pune seeks a QA/QMS professional to drive auditing and certification projects for ISO 9001:2015 and ISO 13485:2016. You will prepare QMS documentation, plan audits, and coordinate with medical device and pharma clients. Prior MR experience and CDSCO/US FDA knowledge are a plus.

Ideal candidates hold life sciences credentials and have hands-on QA/QMS work, with strong communication to support compliant, efficient systems across industries.

Qualifications

• Experience with ISO 9001:2015 and ISO 13485:2016 implementations.
• Background in medical devices or pharma industries or QMS certified Industry.
• Experience as Management Representative or in similar roles.
• Knowledge of CDSCO registration and US FDA registration/510K is an advantage.
• Strong documentation and auditing capabilities.

Responsibilities

• Plan and conduct audits in line with QMS standards.
• Prepare and maintain QMS documentation and technical files.
• Coordinate certification projects with clients and auditors.
• Support implementation and continual improvement of quality systems.
• Interact with certification bodies and regulatory authorities.

Skills

Auditing

QMS Implementation

Audit Planning

Quality Management

Management Representative

CDSCO Registration

US FDA Registration Knowledge

Education

BSc

MSc

BE

Biotechnology

Biochemistry

Microbiology

Life Sciences

Tools

QMS Documentation

Technical File Preparation

Job description

• Auditing experience
• Knowledge of QMS Documentation and Implementation in ISO 9001:2015, ISO 13485:2016 etc
• Worked in ISO certified Quality Management System Company
• Preparing QMS Documentations ISO 9001, ISO 13485
• Should have Knowledge in Quality Management System
• Should plan the audits
• Handling projects in certification
• Good communication skills
• Added advantage
• Worked as Management Representative in any organization
• Worked with QMS Consultant or Certification Body.
• CDSCO Registration
• Knowledge of Usfda registration / 510K
• Preference worked in medical device Industry.

Qualification : -

• Bsc/Msc/ BE/ Biotechnology / Biochemistry / Microbiology/ Life sciences
• QMS Documentation, Implementation and preparation of Technical files / QMS Auditor
• Should have background in either Medical devices or Pharma Industries or QMS certified Industry.