Quality Assurance Executive for Sterile Medical Devices

22 hours ago

Hyderabad, Telangana, India beBeequality Full time ₹ 12,00,000 - ₹ 18,00,000
Quality Control Specialist: Ensure Excellence in Sterile Medical Devices

This role is crucial to ensuring that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. The ideal candidate must have a strong understanding of regulatory requirements such as ISO 13485, Indian Medical Device Rule-2017 etc., with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment.

Key Responsibilities:
  • Supervise Team Performance: Oversee the team's performance in-process and final inspection of sterile medical devices and components.
  • Conduct Sampling and Testing: Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc.
  • Customer Complaint Investigation: Involve customer complaint investigation process and prepare necessary investigation reports.
  • Ensure Regulatory Compliance: Ensure compliance with applicable regulatory standards (ISO 13485, IMDR, MDR etc.).
  • Maintain QC Instruments: Maintain and calibrate QC instruments and equipment.
  • Prepare QC Documentation: Prepare and review QC documentation, including SOPs, inspection reports, COA, and deviation reports.
  • Participate in Audits: Participate in internal audits and support external regulatory inspections.
  • Identify and Report Non-Conformities: Identify and report non-conformities and assist in root cause analysis and CAPA implementation.
Qualifications & Skills:
  • Bachelor's Degree: Bachelors degree in Science, Engineering, Pharmacy, or a related field.
  • Quality Control Experience: 4-6 years of experience in quality control within the medical device industry.
  • Familiarity with Regulations: Familiarity with GMP, ISO 13485, and IMDR regulations.
  • QC Tools and Instruments: Proficient in using QC tools and instruments.
  • Documentation and Analytical Skills: Strong documentation and analytical skills.
  • Communication and Teamwork: Good communication and teamwork abilities.
  • Statistical Quality Control: Experience with statistical quality control (SQC) and SPC tools.

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