Ensure that the company's quality system is in compliance with the regulations of FDA, ISO and Canadian Regulations.
Main Responsibilities :
Ensure that manufactured products meet specifications.
Ensure that manufacturing methods as well as inspections comply with procedures and regulations.
Maintain control of the DHR.
Maintain the quality system documentation system.
Maintain the evidence of the training of the personnel involved in the quality system.
Ensure through the receipt inspection that the components are in accordance with specifications.
Maintain the process statistics to measure the effectiveness of the process according to the quality objectives.
Verification of the manufacturing equipment that is operating within the authorized parameters through validations.
Ensure that the clean room environment complies with the authorized operating parameters.
Communicate all customer complaints related to the quality system.
Investigate customer complaints to get to the root of the problem and take preventive actions.
Maintain a process of communication and corrective actions with the suppliers of components as well as services through the SCARs.
Maintain an effective control plan for insects and rodents.
REQUIREMENTS : Education : Bachelor’s degree on industrial Engineering Experience :
At least three years in the area of quality control in medical products
Technical skills :
Bilingual (English - Spanish) spoken and written
Knowledge of FDA / ISO regulations
Interpersonal skills : Leadership