Company Description Amtech Medidevices Pvt. Ltd. is a research-driven medical device company with over 20 years of experience delivering innovative and reliable surgical solutions. The company specializes in 3D printed custom patient-specific implants, orthopedic, CMF and neuro solutions, trauma and spine implants, surgical instruments and cutting guides, anatomical bone models, and advanced hospital IT solutions.

Its mission is to empower surgeons and healthcare institutions with precision-driven tools, enhance surgical accuracy and safety, and improve patient outcomes.

Amtech

Medidevices provides high-quality, certified solutions and holds ISO 13485 and CDSCO certifications. The company is trusted by hospitals and surgeons worldwide for complex surgical procedures and advanced medical technology.

Role Description The QA/QC role at Amtech Medidevices Pvt. Ltd. is a full-time, on-site position based in the Pune/Pimpri-Chinchwad area. The role involves performing routine quality inspections of medical devices and components, monitoring production processes for compliance with internal standards and regulatory requirements, and documenting quality findings in an accurate and timely manner.

Responsibilities include supporting validation activities, maintaining quality records,



assisting in root cause analysis and corrective and preventive actions (CAPA), and participating in internal audits. The role also includes collaborating with production, R&D;, and regulatory teams to ensure quality standards are met across the product lifecycle and contributing to continuous improvement initiatives.

Qualifications

- Candidates should possess strong skills in Quality Control and Quality Assurance.
- Candidates should possess skills in Quality Management and familiarity with medical device quality systems.
- Candidates should possess knowledge of Good Manufacturing Practice (GMP) and related regulatory requirements.
- Candidates should possess experience in Quality Auditing and internal audit processes.
- Relevant degree or diploma in engineering, biomedical, quality, or a related field.
- Experience in the medical device, healthcare, or pharmaceutical sector is preferred.
- Robust attention to detail, analytical mindset, and ability to interpret technical documentation.
- Effective communication skills and ability to work collaboratively in cross-functional teams.
- Familiarity with ISO 13485 and other applicable quality standards is an advantage.

📌 QA/QC (India)
🏢 Amtech Medidevices
📍 India