Quality Control Engineer

Company:

Adiuvo Diagnostics Pvt. Ltd.

www.adiuvodiagnostics.com

Job Title:

Quality Control Engineer

About Us:

Adiuvo Diagnostics is a deep-tech medical startup developing next-generation diagnostic solutions. Our interdisciplinary team combines expertise in optics, electronics, microbiology, and artificial intelligence to create innovative point-of-care medical technologies.

Role Summary:

Quality Control Engineer

Key Responsibilities

• Supplier Quality Management

• Evaluate and qualify suppliers to ensure adherence to company and regulatory quality standards.

• Conduct supplier audits and drive corrective actions for non-conformances.
• Monitor supplier performance and maintain compliance records.

• Incoming Material & Component Inspection

• Establish inspection criteria, sampling plans, and acceptance standards for raw materials and components.

• Perform and oversee incoming inspections using precision instruments (calipers, micrometers, gauges, spectrometers, etc.).
• Document non-conformances and coordinate with suppliers for corrective and preventive actions.

• Quality Systems & Compliance

• Ensure compliance with ISO 13485, ISO 9001, and medical device regulatory standards.

• Maintain accurate inspection records, certificates of analysis, and quality reports.
• Participate in risk assessment, root cause analysis, and CAPA processes.

• Cross-Functional Collaboration

• Work closely with Procurement, R&D, and Manufacturing teams to resolve supplier-related quality issues.

• Support new product development by validating supplier materials and components.
• Train team members on inspection methods and quality best practices.

Required Skills & Experience

• Bachelor’s degree in Mechanical, Electronics, Biomedical, or Industrial Engineering (or related field).
• 2–5 years of experience in

  supplier quality control, incoming inspection, or QC roles

  , preferably in medical devices, electronics, or precision manufacturing.
• Strong knowledge of

  quality tools

  : 8D, RCA, CAPA, FMEA, and statistical process control.
• Hands-on experience with measurement and testing instruments.
• Familiarity with

  ISO 13485 / ISO 9001

  quality management systems.
• Strong analytical and communication skills; ability to work cross-functionally.

Nice to Have

• Prior experience in

  medical devices, diagnostics, or regulated industries

  .
• Exposure to regulatory requirements (e.g., CE, FDA, IVD).
• Knowledge of supplier development programs and lean quality systems.