2 annunci per il ruolo di it consultant - roma, laz (recruiting in corso)

Quality Engineer
Cosmo Pharmaceuticals —Roma, Lazio
- Inglese
- Sviluppo software
Categorie Protette - Experienced Regulatory
Deloitte —Roma, Lazio
- Inglese

More jobs to discover

Find similar jobs that you might be interested in.

Categorie Protette - Experienced Regulatory
Deloitte —Roma, Lazio
I servizi includono Audit & Assurance, Technology & Transformation, Strategy, Risk & Transactions Advisory e Tax & Legal.

Voglio ricevere gli ultimi avvisi Job Alert per il ruolo di it consultant nella seguente località: roma, laz

Accedendo al tuo account, accetti i Termini di Servizio di SimplyHired e acconsenti alle nostre Norme sui Cookie e sulla Privacy.

Quality Engineer

Cosmo Pharmaceuticals
Roma, Lazio

Candidati adesso

Dettagli della posizione

Qualifiche

Inglese
Gestione della qualità
Sviluppo software

Descrizione completa della posizione

PURPOSE

MedTech AI - Engineering

LOCATION

Rome

Description

We're seeking a Quality Engineer to join our R&D team to support the development of cutting-edge Intelligent Medical Devices. Your primary responsibility will be to ensure that our medical devices meet the quality and safety standards required by industry regulations. You will closely collaborate with software development, engineering, and regulatory functions to ensure the success of our innovative and life-saving product portfolio.

KEY RESPONSIBILITIES

Software and Hardware Verification , Validation
Development and management of technical documentation
Ensure that the design team develops the product according to Operating Procedures
Draft and/or revise procedures and checklists for production (e.g., assembly, software installation, product release...)
Draft and revise protocol for end-of-line testing
Label management and control
Documentation management and review: archiving, maintaining a file for checking produced serials
Design transfer and training activities
CAPA management: non-conformance management and compliant, root cause analysis

QUALIFICATIONS, SKILLS AND ABILITIES

Qualification – Required Knowledge, Skills and Abilities

Knowledge of IEC/EN 60601-1 and IEC/EN 60601-1-2
Knowledge of IEC 62304
Knowledge of 2017/745(MDR) and 21 CFR 820
Knowledge of 21 CFR part 11
Ability to write and review all project related Documentation (FRS, SRS, SDS, HRS, HDS, etc.)
Familiarity with medical software development and software development processes in compliance with regulations.

Minimum Required Education and Experience

3+ Experience in the role (highly desirable)
Life science or Engineering education
Knowledge of ISO 9001, ISO 13485, 93/42/CEE (MDD)
Good English Level (writing and speaking)

OTHER REQUIREMENTS

Physical Requirements

Expected travel is 20%

APPLICATION

Email us with your CV, résumé or portfolio, and a cover letter explaining your motivation for applying. Please include the job title in your email subject line.

Please review our privacy notice for job applicants

Thanking you for your application and for sending your CV, pursuant to art. 13 and 14 of the General Data Protection Regulation (EU) 2016/679, we provide you with all the necessary information relating to the processing of your personal data. The processed data will be your personal data that you deem appropriate to include in your CV. We invite you not to provide in your CV Personal Data falling within the special category of Personal Data pursuant to art. 9 of EU Regulation no. 679/2016(such as, for example, racial or ethnic origin, political opinions, religious or philosophical beliefs, union membership, data relating to the person's health or sex life or sexual orientation). We therefore reserve the right to delete or make anonymous such data if it is entered anyway. We inform you that your personal data will be processed in order to carry out an objective assessment of your professional and personal requirements in relation to the possibility of hiring for an open position, or future contact in the event of the opening of new positions relating to your professional figure. In compliance with the Art. 6 of the Regulation, the Data Processing is necessary to take steps at the request of the data subject prior to entering into a contract. The personal data being processed are provided directly by you; during an interview, the Data Controller may collect further data, including particular data, collected directly from you or from other sources; personal data from public registers may also constitute processing, always for purposes connected with the correct management of the employment relationship; during the interview you will be given specific information. All the aforementioned data will be kept for a period of 1 year and only in the event of the establishment of the employment relationship will they be kept for the entire duration of the contract and in relation to the terms established by the relevant legal obligations. Without prejudice to communications made in compliance with legal obligations, all data collected and processed may be communicated to categories of subjects such as the personnel office, function or area managers, group companies and labor consultants. The rights enshrined in the Regulation (access, rectification, cancellation, restriction and opposition, portability, and the right to lodge a complaint with the Authority) may be exercised against the Data Controller by writing to the following e-mail address: [email protected] For more information, please view the complete privacy policy at the link: cosmohealthconfidence/privacy-policy

Candidati adesso

Perfeziona la tua ricerca

it consultant offerte - roma, laz

Quality Engineer

Categorie Protette - Experienced Regulatory

More jobs to discover

Voglio ricevere gli ultimi avvisi Job Alert per il ruolo di it consultant nella seguente località: roma, laz

Related Searches

Strumenti per chi cerca lavoro

Strumenti Aziende

Visualizza

Resta in contatto