Location
Pune | India
Job description
About Noccarc:
Noccarc is building smart medical devices, and a software ecosystem around these devices. We started our journey with ventilators and have already established a significant presence in the market with over 3600 Noccarc V310 ICU Ventilators installed in 650+ hospitals across 260+ cities. Our team size has grown to 80 people, and we have an extensive R&D team of 30 individuals from top institutes of the country, and have a manufacturing unit in Pune.
To know more about Noccarc visit:
Position Overview :
We are currently seeking a highly skilled Quality Engineer with a background in electronics (Hardware & Programming) and experience in the medical device manufacturing environment. The successful candidate will be responsible for ensuring the quality and reliability of our devices and systems throughout the manufacturing process. They will work closely with cross-functional teams to implement robust quality systems and processes that adhere to regulatory standards and industry best practices.
Location :
Responsibilities :
- Develop and maintain quality control systems and procedures specific to the medical device manufacturing environment, ensuring compliance with regulatory requirements such as ISO 13485.
- Collaborate with design and manufacturing teams to ensure that electronic components and systems meet quality and reliability specifications for medical device applications.
- Conduct risk assessments and implement risk mitigation strategies tailored to the unique requirements of medical device manufacturing.
- Lead failure analysis investigations and root cause analyses to address quality issues and implement effective corrective and preventive actions.
- Generate and maintain documentation including quality plans, inspection procedures, technical reports, and validation documentation required for regulatory submissions.
- Support internal and external quality audits and inspections, addressing any findings and implementing corrective actions as necessary.
- Provide guidance and training to manufacturing personnel on quality processes, procedures, and regulatory requirements specific to medical device manufacturing.
- Participate in supplier evaluation and qualification processes, ensuring the quality and reliability of electronic components and materials used in medical device manufacturing.
- Design, develop and maintain the testing jigs used for inspection of critical parts and subassemblies.
- Oversee the calibration and maintenance of measuring instruments and equipment used in quality control processes, ensuring accuracy and compliance with regulatory standards.
Qualifications :
- Bachelor's degree in Electronics Engineering & related field.
- 46 years of experience in quality engineering or related roles in the electronics industry, with specific experience in medical device manufacturing.
- Strong understanding of quality management systems, regulatory requirements, and industry standards applicable to medical device manufacturing (e.g., ISO 13485, CDSCO regulations).
- Strong understanding of electronic components, circuits, systems, PCB schematic diagrams and Gerber files.
- Experience with risk management methodologies such as QAP and PFMEA, with a focus on medical device applications.
- Proficiency in statistical analysis tools and techniques for quality assurance and process improvement.
- Excellent problem-solving skills with a systematic approach to root cause analysis.
- Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams in a fast-paced environment.
- Detail-oriented with a commitment to maintaining high standards of quality, compliance, and patient safety in medical device manufacturing.
Skills :
- Lean Six Sigma Green Belt
- Programming equivalent to Arduino & STM32.
- Basic Understating of Embedded C
- Good expertise in Microsoft Products (Excel, SharePoint, Teams, Etc.)
- Expertise in Electronic BOM evaluation.
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