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.
- Valuable 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

📌 QA Engineer -Healthcare (Vasai-Virar)
🏢 Aviyana venture
📍 Vasai-Virar