Job Description

Key Responsibilities

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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 10993). 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

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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

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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