JOB DESCRIPTION
QA Manager & Product Design Engineer – Medical Devices
Company: Medverse Healthcare Pvt. Ltd.
Location: Vasai East, Maharashtra
Department: Quality Assurance / Regulatory / Product Development
Position: QA Manager & Product Design Engineer
Reporting To: Director / Management
Employment Type: Full-Time
Role Overview
We are looking for a QA Manager with experience in medical-device manufacturing who will be
responsible for managing Medverse's Quality Management System, quality control, regulatory
documentation and manufacturing quality.
In addition, the candidate must have hands-on knowledge of SolidWorks and be capable of
independently designing and modifying machines, components, assemblies and spare parts.
Key Responsibilities
- Manage and maintain the QMS as per ISO 13485 and applicable medical-device
requirements.
- Manage SOPs, work instructions, quality records and document control.
- Handle NCR, CAPA, root-cause analysis and corrective actions.
- Conduct internal audits and support CDSCO, customer and other regulatory
audits/inspections.
- Ensure quality control of incoming materials, production processes and finished products.
- Handle supplier quality issues and coordinate corrective actions with vendors.
- Support CDSCO and other regulatory documentation and ensure compliance requirements
are met.
- Maintain product quality, inspection standards and traceability.
SolidWorks & Product Design
- Create and modify 3D models and 2D manufacturing drawings using SolidWorks.
- Design and develop machine components, assemblies, brackets, housings and spare parts.
- Prepare and maintain BOMs, part numbers and drawing revisions.
- Modify existing designs based on production, service or customer requirements.
- Develop replacement/alternate spare parts where required.
- Coordinate with production and vendors to ensure designs are practical and
manufacturable.
- Maintain proper drawing, BOM and engineering change control.
Candidate Requirements
- Degree/Diploma in Mechanical / Production / Biomedical Engineering or related field.
- 5+ years of relevant experience, preferably in medical-device manufacturing.
- Strong practical knowledge of ISO 13485, QMS, CAPA, NCR and audits.
- Working knowledge of CDSCO medical-device requirements will be an advantage.
- Hands-on SolidWorks experience is essential.
- Good understanding of mechanical drawings, dimensions, tolerances and manufacturing
processes.
- Ability to work independently and coordinate with production, purchase, service and
vendors.
- Good documentation, communication and problem-solving skills.
Key Expectation
The ideal candidate should be hands-on and practical — capable of managing Medverse's QA/QMS
requirements while also supporting the company in machine design, engineering
Pay: Up to ₹35,000.00 per month
Work Location: In person
