Production Specialist
2 giorni fa
Tensive, a leading biomedical startup, is seeking a highly skilled Production Specialist to join our team. In this role, you will be responsible for supporting production and quality control activities in our ISO 7 cleanroom, where we develop innovative prostheses for breast reconstruction and augmentation.
We are looking for a collaborative individual with a passion for learning and a strong teamwork spirit. Our team invests heavily in coaching new hires to ensure their success in this challenging role.
Key Responsibilities:- Manufacturing Activities: Perform manufacturing tasks in our ISO 7 cleanroom for Class III medical devices, adhering to strict quality standards.
- Quality Control: Conduct quality control tests on production intermediates and final products, following internal procedures and applicable standards.
- Non-Conformities: Participate in the management of non-conformities, including drafting reports, investigating root causes, and implementing preventive and corrective actions.
- Risk Assessments: Collaborate in risk assessments of the manufacturing process and validate the manufacturing process to ensure compliance.
- Equipment Qualification: Perform installation qualification, operation qualification, and performance qualification of equipment involved in production.
- Cleanroom Monitoring: Participate in the monitoring of environmental conditions and parameters of the cleanroom.
- Maintenance and Cleaning: Perform ordinary and extraordinary maintenance of equipment, as well as cleaning of the equipment, cleanroom, and related documentation.
- Experience: Previous work experience in the production of medical devices Class III or the pharmaceutical field, with knowledge of quality management systems.
- Education: Technical Diploma or Bachelor's degree in scientific or technical disciplines.
- Work Environment: Willingness to work in a controlled cleanroom environment, which involves wearing relevant clothing and personal protective equipment.
- Knowledge: Good knowledge of organizational, operational, and technical aspects of the production of medical devices or pharmaceutical products.
- Language: Good knowledge of the English language, spoken and written.
- Software Skills: Good knowledge of the Microsoft office package.
If you are a motivated and detail-oriented individual with experience in production and quality control, we encourage you to apply for this exciting opportunity.
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