Job Profile

Proficient in handling regulatory & quality requirements for medical devices ISO 13485 for Dental Prosthesis.

Experience in handling international regulatory requirements, including FDA, EU MDR and other standards will

be preferable.

Handled regulatory submission processes, including preparation of reports and other required documents.

Candidate Profile

Qualification – Any Degree

Experience – 4 to 5 years in RA & QA

Excellent Verbal & written communication skills.

Positive interpersonal skills.

Possess the ability to collaborate and work in a cohesive manner with all the departments and the external agencies

for official requirements.

Well versed in regulatory matters for continuous process improvements and check on quality systems are

implemented.

Joining Time – Immediate to hire.

Suitable candidates please forward resume to [email protected]

About our company:

Dantech Digital Dental is a multinational company specializing in the manufacturing of custom-made devices

within the dental industry. Incorporated in April 2023, we have been exponentially growing and will continue to

do so. Our legacy in dentistry spans more than two generations, providing us with a solid foundation and

unparalleled expertise. The management team, comprising experts in dental products, form the core strength and

value of Dantech. Please visit www.dantechdentallab.com

Detailed Job Profile:

 Ensure quality management system are effectively implemented by all employees across departments

and quality systems are in place.





 Develops quality policies & procedures that help in the consistent manufacture of quality products.

 Conduct regular trainings to the employees on quality practices.

 Draft quality assurance policies & procedures

 Interpret, implement & Evaluate quality assurance standards

 Develop & help in the development of quality documents including quality manuals, SOPs, work

instructions & related formats.

 Monitor the distribution of quality documents in the company .

 Explain the quality policy & objectives to employees & ways to achieve it

Review the implementation & efficiency of quality & inspection systems

 Define the agenda for internal quality audits & conduct periodic internal audits

 Documenting management review meetings & other quality assurance activities

Periodic monitoring of other departments for compliance with SOPs & record keeping

 Collaborate with external auditors to facilitate external audits

 Collect & compile statistical quality data

 Develop, recommend & monitor corrective & preventive actions

Monitor risk management activities

 Analyze customer complaints.

 Conduct process validation.

 Authorize safe disposition of non-conforming products.

 Implementing product re-call and return goods material.

 Implementation of deviation approval request.

And any related work that is associated with the Quality & Regulatory assurance,

Pay: ₹700,000.00 - ₹1,000,000.00 per year

Benefits:

- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

📌 Quality & Regulatory Assurance - QARA - Assistant Manager (India)
🏢 Dantech Digital Dental Solutions
📍 India