1 Opening(s)
5.0 Year(s) To 7.0 Year(s)
10.00 LPA TO 13.00 LPA
POSITION TITLE: Senior QA/RA SpecialistJOB LOCATION: Bangalore,IndiaDEPARTMENT: Quality & RegulatoryREQUIRED EDUCATION: Bachelor’s degree in biomedical engineering discipline or equivalent
engineering degreeKEY RESPONSIBILITIES: ➢ Product QA/RA:
• Provide quality and regulatory affairs input to the productdevelopment team and handle all QA & RA responsibilitiesthroughout product development, design change and post marketsurveillance process• As ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
3.00 LPA TO 3.60 LPA
Knowledge of Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev 4.
Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk.
Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses ...
1 Opening(s)
12.0 Year(s) To 20.0 Year(s)
40.00 LPA TO 60.00 LPA
Position Summary
We are seeking an exceptional leader to drive operational excellence, scale manufacturing capabilities, and achieve global competitiveness while ensuring compliance with CDSCO, EMA, and EU MDR requirements.
Key Responsibilities
Oversee end-to-end manufacturing operations across all sterile/aseptic product lines
Scale production capacity to support 2X revenue growth through CMO partnerships and captive expansion
Drive ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
3.50 LPA TO 5.00 LPA
Assist in ensuring product quality and compliance with regulatory standards, including MDR and QMS requirements.
Support the preparation and maintenance of quality manuals, formats, and SOPs under guidance.
Conduct routine document reviews, including COAs, calibration reports, and sterilization checklists.
Participate in internal audits and assist with audit documentation and follow-ups.
Maintain and update records ...
1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
4.00 LPA TO 6.00 LPA
Job Responsibilities:
Monitoring of inbox, assignment of tasks to others ensuring that all queries have been responded to on time
Artwork review and approval
Creation and maintenance of master labelling specifications
Release of product for further processing at EMP
Creation of international registration documents
Maintenance of technical drive, ensuring document compliance
MDR/Technical file support
Post Market Surveillance – ...
1 Opening(s)
0 To 2.0 Year(s)
4.00 LPA TO 8.00 LPA
Quality Engineer Standards and Regulations Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971
, MDD, MDR, 510(k) etc.) Ensuring compliance of products as per MI PLM and SHPL QMS requirements Co-ordination with Quality Assurance Manager on various
SHPL QMS related activities Conducting/participating in Internal Audits and ...
1 Opening(s)
3.0 Year(s) To 5.0 Year(s)
2.00 LPA TO 5.00 LPA
Quality Engineer Standards and Regulations Good knowledge of the relevant Standards/Regulations for medical device manufacturers
(ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.) Ensuring compliance of products as per MI PLM and SHPL QMS requirements Co-ordination
with Quality Assurance Manager on various SHPL QMS related activities Conducting/participating in Internal Audits and External ...
1 Opening(s)
0 To 1.0 Year(s)
1.20 LPA TO 1.80 LPA
The Asst Production Chemist is responsible for planning, supervising, and executing manufacturing activities to ensure products are produced safely, efficiently, and in compliance with cGMP, ISO 13485 (where applicable), Medical Device Rules (MDR) 2017, approved procedures, and company quality standards. The role includes manpower supervision, production planning, documentation, equipment utilization, ...
1 Opening(s)
5.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
Job SummaryWe are seeking an experienced Static Equipment Design Engineer to design, analyse, andmaintain critical static equipment used in various industrial processes. The successfulcandidate will work closely with cross-functional teams to ensure all equipment meetssafety standards, efficiency metrics, and regulatory compliance.Key ResponsibilitiesDesign & Engineering: Develop detailed designs, specifications, and data ...
1 Opening(s)
4.0 Year(s) To 8.0 Year(s)
4.00 LPA TO 7.00 LPA
Key tasks and responsibilities
Document Creation and Formatting:
Create templates for various types of documents. Developing and implementing quality standards & quality control
Periodic review of Quality Management System (QMS) system and improvising to meet the industry standards.
Reviewing reports of testing materials, equipment certificates, processes and products as per approved Inspection and Test Plan (ITP) & project specification to ...