Production & Quality Control Specialist - Biomedical Manufacturing

Amygdal; Milano; In loco; EUR 25.000 - 30.000; Tempo pieno

Descrizione del lavoro

A leading MedTech startup in Milan is seeking a Production & Quality Control Specialist to support activities in a cleanroom environment. The ideal candidate will have experience in producing Class III medical devices, knowledge of quality management systems, and a technical degree. This permanent position offers a salary between €25,000 and €30,000 annually.

Competenze

• Previous work experience in the production of Class III medical devices is encouraged.
• Knowledge of organizational and operational aspects of medical device production.

Mansioni

• Perform manufacturing activities in ISO 7 cleanroom for Class III medical devices.
• Conduct quality control tests on production intermediates and final products.
• Participate in the management of non-conformities and drafting of reports.

Conoscenze

Knowledge of quality management systems

Good knowledge of Microsoft Office

Good knowledge of English

Formazione

Technical Diploma or Bachelor's degree in scientific or technical disciplines

Descrizione del lavoro

Our client, a leading MedTech startup specializing in the development of innovative and biodegradable prostheses for natural breast reconstruction, is looking for a :

• Production & Quality Control Specialist - Biomedical Manufacturing

The role supports Production and Quality Control activities in a cleanroom environment, handling testing, qualification, maintenance, and process improvement in accordance with company guidelines and industry standards.

Responsibilities

1. a. Performs manufacturing activities in ISO 7 cleanroom for Class III medical devices;
2. b. Performs quality control tests on the production intermediates and the final product according to internal procedures and applicable standards;
3. c. Participates in the management of non-conformities, including drafting reports, investigating root causes, implementing preventive and corrective actions, and drafting related documents;
4. d. Participates in risk assessments of the manufacturing process and validation of the manufacturing process;
5. e. Performs installation qualification, operation qualification, and performance qualification of equipment involved in production;
6. f. Participates in monitoring environmental conditions and parameters of the cleanroom;
7. g. Performs maintenance of equipment;
8. h. Performs cleaning of equipment and cleanroom, and updates related records;
9. i. Maintains production templates, records, registries, and documentation;
10. j. Drafts and updates Standard Operating Procedures (SOPs) and operating instructions (WIs);
11. k. Verifies maintenance and calibration status of production equipment;
12. l. Checks the calibration status of instruments used in production.

Requirements

• Previous work experience in the production of Class III medical devices or in the pharmaceutical field, with knowledge of quality management systems, is encouraged and will be positively evaluated.
• Technical Diploma or Bachelor’s degree in scientific or technical disciplines;
• Knowledge of organizational, operational, and technical aspects of medical device or pharmaceutical production;
• Good knowledge of English, spoken and written;
• Good knowledge of Microsoft Office.

Work location

Milan

Job Type

Permanent

Pay

€25,000.00 - €30,000.00 per year

Education

• Bachelor's degree (preferred)

Experience

• Production of medical devices: 2 years (preferred)