Laboratory Specialist – Medical Device Manufacturing

3 weeks ago

Bengaluru, India Pragathi IT Ads Private Limited Full time

Key Responsibilities:

  • Conduct physical, chemical, and mechanical testing of raw materials and finished products (e.g., transparency, inner/outer diameter, tensile strength, burst pressure, flow rate, thermal resistance).
  • Operate and maintain lab equipment such as Vernier calipers, tensile testers, flow meters, FTIR, microscopes, etc.
  • Document and analyze test results according to quality management systems (QMS) and Good Manufacturing Practices (GMP).
  • Assist in product validation and verification activities.
  • Participate in non-conformance investigations and provide technical insights.
  • Ensure compliance with international standards (e.g., ISO 5367, ISO 80369, ISO
  • Prepare accurate lab reports and support internal audits and regulatory inspections.
  • Adhere to laboratory safety protocols and maintain a clean, organized workspace.
  • Perform routine and specialized cleaning of cleanroom facilities, equipment, and instruments to meet stringent contamination standards.
  • Track and document key environmental parameters, such as particle counts, temperature, and humidity, to ensure they stay within established limits.
  • · Handle and operate specialized equipment and machinery within the cleanroom, ensuring proper use and maintenance.

Qualifications:

  • Bachelor's degree in Laboratory Sciences, Chemistry, Biomedical Engineering, or a related field.
  • Minimum 1–3 years of experience in a laboratory or quality control role, preferably in the medical device or pharmaceutical industry.
  • Familiarity with ISO 13485 and cleanroom/controlled environment practices.
  • Strong understanding of quality assurance principles and testing procedures.
  • Proficient in Microsoft Office (especially Excel); experience with LIMS or digital QC systems is a plus.
  • Excellent analytical, documentation, and communication skills.
  • Perform routine and specialized cleaning of cleanroom facilities, equipment, and instruments to meet stringent contamination standards.
  • Handle and operate specialized equipment and machinery within the cleanroom, ensuring proper use and maintenance.

Salary & Benefits:

  • Competitive salary based on experience.
  • Health insurance and other allowances.
  • Opportunities for professional development and training.

Work Environment

  • Controlled Environment: Work in highly controlled, sterile environments designed to prevent particle and microbial contamination.
  • Specialized Garb: Required to wear specialized cleanroom attire or "bunny suits".
  • Strict Entry/Exit Procedures: Must follow strict protocols for entering and leaving the cleanroom, including gowning and degowning procedures

Job Types: Full-time, Permanent

Work Location: In person

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