Job Title

Quality Assurance Executive

No of Vacancy: 1

Job Location: Mira Road/Boisar

Years of Experience: 4-8 years

Working Days: Monday to Saturday

Job Summary:

We are looking for a dedicated and experienced Quality Assurance Executive to lead and support quality system compliance across all business functions. The ideal candidate will bring a deep understanding of ISO 13485 , 21 CFR Part 820 , and Schedule V of MDR 2017 , along with robust documentation, auditing, and process validation expertise. This role is critical to ensuring our products, systems, and processes meet global regulatory and quality standards.

Key Responsibilities:

Ensure ongoing compliance of the Quality Management System (QMS) across departments and business units

Lead the preparation and maintenance of Standard Operating Procedures (SOPs) , Work Instructions , and Plant/Site Master Files

Drive and oversee internal and external audits , including regulatory and customer audits

Support process validation activities and ensure documentation meets compliance requirements

Conduct gap analyses for changes in global quality regulations and implement necessary updates

Propose and coordinate effective Corrective and Preventive Actions (CAPA) in response to audit findings and quality events

Lead and facilitate management review meetings , ensuring actionable insights are derived from compliance data

Develop and deliver company-wide quality training materials and competency-building initiatives

Generate and present monthly and quarterly reports on QMS performance to senior management





Identify and implement system-wide process improvements in collaboration with cross-functional teams

Manage direct or dotted-line reporting team members, fostering a culture of continuous improvement and compliance

Educational Qualifications:

Bachelor's and/or Master's degree in Pharmaceutical Sciences , Engineering , Biotechnology , Microbiology , or a related life science discipline

Preferred specialization in Regulatory Affairs or Quality Assurance

Key Skills & Competencies:

Excellent scientific writing , documentation , and presentation skills

In-depth knowledge of ISO 13485 , 21 CFR Part 820 , and Schedule V of MDR 2017

Understanding of MDSAP and other global quality standards (preferred)

Hands-on experience in:

- SOP and technical documentation preparation
- Plant/Site Master File creation
- Process validation support and documentation
- Quality audits (internal and external)
- CAPA, non-conformity handling, and regulatory compliance

Familiarity with data analysis and reporting tools People management and team coordination experience (preferred)

Soft Skills:

Proactive, go-getter attitude with a passion for quality

Strong English communication skills (verbal and written)

Ability to lead initiatives , mentor junior team members, and present to leadership

Avid learner with a willingness to share knowledge and enhance team competency.

Strong collaborative mindset and ability to work across functions

Problem-solving ability and ownership mindset in managing compliance challenges

Monday to Saturday working

Company Website:

https://www.laxmidentallimited.com/

https://www.illusiondentallab.com/

https://www.illusionaligners.com/

📌 Quality Assurance Executive (Mumbai)
🏢 Laxmi Dental
📍 Mumbai