QA Laboratory Analyst (Medical Devices)

About the role

We are looking for a QA Laboratory Analyst to support our medical‑technology laboratory. The role involves ensuring compliance with quality standards, performing chemical and microbiological tests, and contributing to continuous improvement of laboratory processes.

Key responsibilities

• Coordinate documentation to meet GLP, cGMP, ISO and other regulatory standards.
• Investigate process deviations, perform root‑cause analysis and support corrective actions.
• Develop, validate and execute test methods for chemicals and biological samples using chromatography, spectroscopy, dissolution and other techniques.
• Operate, maintain and calibrate laboratory equipment; manage equipment issues and calibration schedules.
• Test incoming chemicals for specification compliance and manage inventory within expiry periods.
• Maintain a safe work environment, implement safety protocols and ensure proper laboratory organization.
• Review and validate test data, document results and support validation activities.
• Participate in continuous‑improvement projects and follow Quality System Regulations.
• Perform duties assigned by the QA Laboratory Supervisor, including support for both chemistry and microbiology testing.

Required profile

• Bachelor’s degree in Chemistry (preferred), Biology or Microbiology.
• 1‑3 years of laboratory experience, preferably in medical‑device or pharmaceutical environments.
• Bilingual English/Spanish with strong written and oral communication skills.
• Normal color perception and accurate mathematical calculation ability.
• Team‑oriented, analytical and quality‑focused mindset.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Publisher).

Required skills

• Chromatography
• Spectroscopy
• Dissolution testing
• GLP, cGMP and ISO regulatory knowledge
• Laboratory equipment operation and calibration
• Inventory management
• Bilingual English/Spanish