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

Company Website :

https : / / www.laxmidentallimited.com /

https : / / www.illusiondentallab.com /