4493 - DIRETTORE TECNICO

Date
27/01/2023

Profile
4493 - DIRETTORE TECNICO

Location
Chiasso (TI)

Detail

ER Services Sagl ricerca una/un DIRETTORE TECNICO per azienda cliente di Chiasso attiva nel settore medicale.

 

Responsabilità

·        Processi di monitoraggio dei requisiti normativi applicabili ai dispositivi medici;

·        Processi di progettazione e sviluppo dei dispositivi medici;

·        Processi di produzione dei dispositivi medici;

·        Processi di approvvigionamento dei beni e dei componenti dei dispositivi medici;

·        Processi di gestione del magazzino;

·        Processi di assistenza postvendita;

·        Processi di controllo qualità;

·        Processi di gestione del laboratorio.

 

Requisiti

·        Laurea magistrale in ingegneria biomedica/meccanica/elettronica;

·        Buona conoscenza lingua inglese;

·        Capacità di interfacciarsi con i progettisti dei dispositivi medici prodotti dall’Azienda;

·        Capacità di sviluppare dispositivi medici a fronte di attività di ricerca e sviluppo;

·        Capacità di verificare il rispetto dei requisiti regolamentari applicabili ai dispositivi medici prodotti;

·        Capacità di valutare i rischi associati ai dispositivi medici fin dalle fasi di progettazione;

·        Capacità di sovrintendere alla realizzazione dei dispositivi medici, in conformità alle specifiche di progetto, con riferimento sia alle normative applicabili, che alle caratteristiche dei dispositivi prodotti dall’Azienda, nello specifico: dispositivi elettromedicali di classe IIa e IIb;

·        Capacità di controllare la qualità dei dispositivi medici in fase di realizzazione e rilascio;

·        Capacità di assicurare la qualità e la conformità dei processi di progettazione e sviluppo, di approvvigionamento, e di realizzazione dei dispositivi medici, interfacciandosi con il Responsabile Gestione Qualità;

·        Capacità di applicare le linee guida dello standard ISO 19011 per lo svolgimento di audit di seconda parte sui fornitori;

·        Capacità di applicare principi di project management nella gestione delle commesse e delle attività ricerca e sviluppo e di progettazione

·        Capacità di gestire gli approvvigionamenti, relativamente alla qualifica, valutazione e gestione dei fornitori e dei contratti di fornitura, inclusi i processi affidati in outsourcing;

·        Capacità di identificare ed applicare i requisiti regolamentari riferibili ai dispositivi medici prodotti;

·        Capacità di predisporre ed aggiornare la documentazione tecnica.

 

Sede di lavoro: Chiasso.


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Terms of conditions

The CV received will be considered "current" for a period of approximately 2 years, after this period the candidate may be required to send an update, it is also in the candidate's interest to inform FRAG of changes in the activities carried out and in the different positions of responsibility taken, this will allow FRAG to verify with a good chance of success the placement of the candidate at expected job opportunities.

Privacy

Dear User,
We wish to inform you, in your capacity as "interested" in the processing of data, that "Regulation (EU) No. 2016/679 of the European Parliament and Council of April 27, 2016 provides for the protection of individuals with regard to the processing of personal data, as well as the free circulation of such data. According to the law, this treatment will be based on the principles of correctness, lawfulness and transparency and protection of your privacy and your rights. According to Article 13 of the Regulation, therefore, we provide you the following information:

1) Purpose of data processing
The data you provide will be used for the following purposes: research and selection of personnel. This activity will be carried out by way of example and not exhaustive: by evaluating your profile, your aptitudes and your professional skills, training courses or carrying out studies and statistical research. The personal data subject to processing are the information present in the curriculum vitae that you will transmit to us (or you have already forwarded to us) and related to personal data, academic qualifications, professional and work experiences, contractual framework, references, duties, motivations for change , aspirations, preferences, etc.

2) Data processing methods
Data processing will be managed as follows: computerized, telematic and paper based, with logic strictly related to the purposes referred to in point 1 and, in any case, in order to guarantee the security and confidentiality of the data. The treatment is carried out by the owner and / or by the persons in charge of the processing.

3) Provision of data and refusal
3.1 - The provision of common personal data, details, former art. 35 of the regulation and judicial is optional but essential and necessary for the purposes of carrying out the activities referred to in the previous point 1).
3.2 - Any refusal by the interested party to provide personal data in the case referred to in this point 3) makes it impossible to carry out the activities referred to in point 1).
3.3. In the event of spontaneous sending of curricula, FRAG SRL may process the personal data contained therein, if of interest to the authorization for the processing of the data contained therein.
3.4 - It may happen that in the curriculum of which FRAG SRL comes into possession, special, criminal or specific risks are also contained. In this case, FRAG SRL may only process data relevant for the purpose of assessing your professional attitude, to the extent that the acquisition of such information is strictly necessary for the establishment of the collaboration relationship and not in contrast with the provisions of the Regulation EU, of the Provisions and General Authorizations of the Guarantor Authority for the protection of personal data, of the Legislative Decree n. 276/2003, of the Law n. 300/1970 (c.d. Statute of workers), of Law n.135 / 1990 as well as with the rules on equal opportunities or aimed at preventing discrimination.
3.5 - We inform you that the provision of the particular data referred to in the previous point 3.4 is required to the extent that it is closely related to the performance of the activity referred to in the previous point 1, when specifically addressed to research and selection of personnel belonging to protected categories . To this end, any failure to provide such particular data or any refusal of written consent to their processing, on your part, would make it impossible for FRAG SRL to proceed with the evaluation of your professional profile considering a correspondence with the needs of the customers of FRAG SRL itself to which the candidacy refers.

4) Data addressees and communications
Personal data may be disclosed to the persons in charge of processing and may be communicated for the purposes referred to in point 1) to employees, external collaborators, client companies that have granted direction to search for candidates and, generally, to all those public and private subjects to whom the communication is necessary for the correct fulfillment of the purposes indicated in point 1. Personal data may also be communicated or otherwise made available to public or private subjects in order to fulfill obligations under laws, regulations or by the Community legislation.

5) Data dissemination and transfer abroad
Personal data are not subject to disclosure. Personal data may be communicated and transferred, for the purposes referred to in point 1, to companies based outside the EU or for the research for candidates in non-EU countries. In case of transfer of data to countries outside the European Union, it will be verified that these countries can guarantee an adequate level of protection on the basis of a specific decision of the European Commission or alternatively the recipient will be contractually obliged to data protection with an adequate level comparable to the protection provided by the GDPR.

6) Data retention
Personal data will be kept for the time strictly necessary for the correct fulfillment of the purposes indicated in point 1. The criteria used to determine the retention period are linked to the duration of the research and selection of personnel, training courses and the performance of statistical and research studies. In any case, the maximum data retention time is estimated at 36 months from the beginning of the processing.

7) Access, rectification, cancellation (right to be forgotten), opposition and data portability
It is your right to ask the data controller the access to personal data and to correct, erase or forget them, or to limit the processing of your personal data or to oppose their processing. It is also your right to request the portability of data, or to obtain the data in a structured format of common use and readable by an automatic device to transmit it to another data controller without hindrance from the data controller.

8) Withdrawal of consent
If the processing, even of particular data, is based on the consent [on the article 6, paragraph 1, letter a) of the Regulation, or on the article 9, paragraph 2, letter a) of the Regulation], it is your right to revoke the very consent at any time without this affecting the lawfulness of the processing based on the consent given before the revocation.

9) Complaint
It is your right to lodge a complaint to the supervisory authority.

10) Profiling
We inform you that no automated decision-making process is used in the processing of your data.

11) Data Controller
The Data Controller is FRAG SRL in the person of its Legal Representative Mr. Francesco Gardoni, with registered and operational headquarters in Via G. Zuretti, 51 20125, Milan, tel. 02 66986749, VAT number 04032290969, mail: info@frag2000.com

12) Rights of the interested party

At any time you can exercise your rights towards the data controller, in accordance with articles 15 and ss of the Regulation, to be understood, here transcribed
The FRAG company reserves the right to preliminary evaluate the CV and to indicate in the e-mail of thanks the consistency of the candidacy to the open position, consequently to the candidates whose experience is consistent with the requested position will be sent an "Informative questionnaire" in order to deepen knowledge of expected working conditions, also in the light of subsequent equivalent job opportunities.
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