Quality Assurance Executive

Job Title : Quality Assurance Executive

No of Vacancy : 1

Job Location : Kochi

Years of Experience : 1-4 years

Working Days : Monday to Saturday

Job Purpose :

We are looking for a detail-oriented and committed Quality Assurance Executive to support and enhance our Quality Management System (QMS) in compliance with ISO 13485 , 21 CFR Part 820 , and other applicable regulatory standards. This role involves document control, audit support, CAPA management, and coordination with internal teams to ensure high-quality standards across operations.

Educational Qualifications :

Bachelor's and / or Master’s degree in Pharmaceutical Sciences , Engineering , Biotechnology , Microbiology , or any relevant Life Sciences discipline.

Specialization in Regulatory Affairs or Quality Assurance is preferred.

Key Skills & Competencies :

Strong understanding of ISO 13485 and 21 CFR 820 requirements

Knowledge of MDSAP standards is a plus

Excellent documentation practices and scientific writing skills

Familiarity with internal audit requirements; Internal Auditor certification preferred

Good presentation and communication skills

Ability to collaborate with cross-functional teams

Professional Experience :

1 to 4 years of hands-on experience in Quality Assurance within a regulated industry such as Medical Devices , Pharmaceuticals , or Life Sciences

Proven experience in :

Preparing and maintaining SOPs, Work Instructions , and other QMS documentation

Managing document control and maintaining regulatory records

Participating in internal and external audits

Supporting CAPA , complaint handling , and feedback mechanisms

Assisting in supplier evaluation , communication, and audit coordination

Key Responsibilities :

Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions in alignment with regulatory standards

Ensure proper document and record control in accordance with ISO 13485 and other applicable quality standards

Participate in quality audits (internal and external) and assist in audit readiness activities

Identify and implement corrective and preventive actions to address non-conformities

Conduct root cause analysis as part of CAPA and complaint handling processes

Present periodic reports on QMS performance and effectiveness to the Quality Head / Management

Collaborate with internal departments to improve compliance and support continuous quality improvement

Assist in setting up and improving feedback and complaint handling systems

Soft Skills & Attributes :

Strong English proficiency – verbal and written

Go-getter attitude and self-motivated

Willingness to learn, lead , and take initiative

Strong sense of accountability and integrity

Excellent team collaboration and interpersonal skills

Ability to work effectively under guidance as well as independently

Monday to Saturday working

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