Medical Devices Auditor

1 giorno fa

Roma, Italia ENGINEERINGUK A tempo pieno

Great that you're thinking about a career with BSI
Auditor Medical Devices (internally known as Client Manager)
Location: Italy - field-based, 70%-75% of travel required within EMEA
We're looking for talented people to join our medical device auditor team. The role involves travelling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits encompass standards such as ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support conformity assessment activities such as those related to UKCA and CE marking.
Responsibilities:
In the first six months of being a Client Manager, you will:
Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)
Initially observe how audits are conducted but then grow to conduct them on an individual basis
In a typical week after being fully trained, you will:
Conduct an audit on site, remotely or hybrid, working alone or as part of a team
Write up your reports and liaise with the planning team and delivery manager to manage your clients and audit schedule
Complete other administrative activities as required
Minimum Requirements:
To be successful you need to have a minimum of 4 years hands-on experience in one or more of the following areas:
research and development
design or design development
servicing, maintenance and or testing
manufacturing or production experience
Covering a range of medical devices which could include:
Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners
IVD (invitro diagnostics) instrumentation and/or reagents
Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Implantable infusion pumps, including Software as a Medical Device
Orthopaedics - spinal implants, bone/dental cements, cartilage, and soft tissue repair
Wound and skin care - dressings, foams, gels
Your experience will also include at least 2 years' working with quality management systems.
You must have completed a university or technical college degree or equivalent in a related STEM subject (BSc, MSc or PhD) such as: Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical, or Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics.
Do you believe the world deserves excellence?
Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries. If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family
D&I Policy
BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

#J-18808-Ljbffr

  • Lead Auditor

    2 settimane fa

    Roma, Italia Ai Brainer A tempo pieno

    Siamo Kiwa, uno dei leader nel settore del Testing, delle Ispezioni e delle Certificazioni (TIC). Operiamo su un’ampia varietà di segmenti di mercato e le nostre aree di specializzazione comprendono, tra gli altri, la Certificazione dei sistemi di gestione, la Certificazione di prodotto, la Corporate Social Responsibility, il Testing e la Metrologia. I...

  • Technical Assessor

    7 mesi fa

    Roma, Italia Bureau Veritas A tempo pieno

    **Come puoi lasciare il tuo segno?** La risorsa si occuperà della valutazione della documentazione técnica e di attività di Audit nel settore **Medical Device non attivi**, in particolare settore dentale (impianti dentali). **Cosa ricerchiamo per avere successo in questa posizione?** - Titolo di studi: Laurea scientifica; - Ottima conoscenza della...

  • Technical Assessor

    7 mesi fa

    Roma, Italia Bureau Veritas A tempo pieno

    **Come puoi lasciare il tuo segno?** La risorsa si occuperà della valutazione della documentazione técnica e di attività di Audit nel settore **Dispositivi Medici Attivi.** **Cosa ricerchiamo per avere successo in questa posizione?** - Titolo di studi: Laurea scientifica; - Ottima conoscenza della lingua inglese; - Esperienza lavorativa nel settore...

  • In-house Clinician, Global Medical Devices

    4 mesi fa

    Roma, Italia SGS A tempo pieno

    **Company Description** We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. As In-house Clinician,...

  • Medical Devices Specialist

    7 giorni fa

    Roma, Lazio, Italia Johnson & Johnson A tempo pieno

    Company OverviewJohnson & Johnson Medical Devices Companies is a leading global medical device company that uses its breadth, scale, and experience to reimagine the way healthcare is delivered. Our corporate philosophy is anchored in our Credo, which inspires and unites the people of Johnson & Johnson. We aim to help people live longer, healthier lives by...

  • Qms Lead Auditor Manager

    7 mesi fa

    Roma, Italia SGS A tempo pieno

    Company Description We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world. **Job...

  • Junior Export Manager Medical Devices

    7 mesi fa

    Roma, Italia Chaberton Italia srl A tempo pieno

    Chaberton Professionals, divisione di Chaberton Partners focalizzata sulla ricerca e selezione di profili di Middle e Top management, è attualmente alla ricerca di un **Junior Export Manager **per una realtà che sviluppa, progetta e brevetta medical devices. **Principali Responsabilità**: - Attività di scouting di nuove opportunità commerciali -...

  • Product Manager

    7 mesi fa

    Roma, Italia Chaberton Italia srl A tempo pieno

    **Chaberton Professionals**, divisione di **Chaberton Partners **dedicata alla ricerca e selezione di profili di Middle Management, è attualmente alla ricerca di un* **Product Manager - Hospital & Medical Devices **per conto di una realtà in forte sviluppo a livello nazionale ed internazionale nel settore Medical Device. - gestire le leve che favoriscono...

  • Product Specialist

    6 giorni fa

    Roma, Italia HAYS A tempo pieno

    Medical Devices - Diabete - Diabetologia - Product Specialist **La tua nuova azienda** *** Il nostro cliente è una società di spicco nell’ambito del Medical Device specializzata nella produzione e distribuzione di sistemi di monitoraggio della glicemia altamente innovativi e siamo alla ricerca di un/a Product Specialist con competenza territoriale...

  • Highly Skilled Medical Devices Specialist for Cardiovascular Expansion

    6 giorni fa

    Roma, Lazio, Italia Johnson & Johnson A tempo pieno

    Job SummaryWe are seeking a highly skilled and experienced Medical Devices Specialist to join our team in Turin, Italy. This is an exciting opportunity to work with our innovative product portfolio and contribute to the expansion of our cardiovascular business.

  • Informatore Scientifico Specialist Medical Devices

    1 settimana fa

    Roma, Italia GUNA A tempo pieno

    **RUOLO**: Informatore Scientifico Specialist Medical Devices - Lazio **DIPARTIMENTO**: ISF / CSC **JOB DESCRIPTION**: Inserita nel Team degli Informatori Scientifici del Farmaco e in collaborazione con i colleghi, la nuova risorsa avrà le seguenti responsabilità: - Mantenere e rafforzare le relazioni con i medici clienti sul territorio, - Ampliare il...

  • Senior Digital Health Engineer

    2 settimane fa

    Roma, Lazio, Italia Analog Devices, Inc. A tempo pieno

    Unlock Breakthroughs in Digital HealthcareAnalog Devices, Inc. is a leading global semiconductor company bridging the physical and digital worlds to enable innovations at the Intelligent Edge.We're seeking an experienced Digital Health Engineer to join our growing design team expanding product portfolios for medical ultrasound, digital X-ray, CT Imaging, and...

  • Qms Lead Auditor Manager

    7 mesi fa

    Roma, Italia SGS A tempo pieno

    Company Description We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world. **Job...

  • Technical Training Specialist, Global Medical

    4 mesi fa

    Roma, Italia SGS A tempo pieno

    **Company Description** We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. The Technical Training...

  • Project Manager

    5 giorni fa

    Roma, Italia HAYS A tempo pieno

    Prodotti medicali e di laboratorio | Advisor | PM **La tua nuova azienda** Il nostro cliente è un’ azienda operante nel settore della cooperazione internazionale e siamo alla ricerca una figura da inserire nel dipartimento di procurement nel ruolo di Advisor/Project Manager. **Il tuo nuovo ruolo** **Di cosa hai bisogno per aver successo** *** È...

  • Mechanical Design Engineer

    2 settimane fa

    Roma, Lazio, Italia Physiol A tempo pieno

    Are you passionate about designing innovative medical devices?  We are seeking a skilled Mechanical Design Engineer to join our R&D team in Rome, Italy. As a key member of our team, you will be responsible for the design and development of mechanical systems and products for ophthalmic surgical devices.  Key Responsibilities:Design and develop medical...

  • Software Developer Leader for Kidney Health Technology

    4 settimane fa

    Roma, Lazio, Italia Mozarc Medical A tempo pieno

    About Mozarc MedicalMozarc Medical is a cutting-edge start-up that aims to revolutionize holistic kidney health technology. Established in 2023, the company was founded through equal investments from DaVita and Medtronic, two industry leaders in kidney care services and medical devices.We put our patients at the center of everything we do, driven by our...

  • Area Manager

    7 mesi fa

    Roma, Italia Wyser A tempo pieno

    Prestigioso Gruppo Multinazionale che sviluppa, progetta, produce, commercializza e vende soluzioni all'avanguardia in ambito medicale, ci ha incaricati di ricercare un: **Area Manager - Medical Device** **_ Lazio Abruzzo e Sardegna_** **_ Principali Responsabilità:_** - Sviluppare relazioni, reti e nuove opportunità di business orientate...

  • International Product Manager

    7 giorni fa

    Roma, Italia IntoCare Medical Technology (SuZhou) Co., Ltd A tempo pieno

    Responsibility: 1. Be responsible for channel management and maintain all stakeholder relationships.. 2. Screen and analyze field market data to develop regional strategic sales strategies, forecast and to meet targets. 3. Management regional sales team including selection, coach, performance review, incentive, and talent retention. 4. Coordinate with all...

  • Medical Statistics Specialist

    3 settimane fa

    Roma, Lazio, Italia Medtronic A tempo pieno

    About the RoleWe are seeking a highly skilled Medical Statistics Specialist to join our dynamic team at Medtronic. This role is an exciting opportunity for individuals with strong analytical skills and experience in biostatistics to contribute to the development of innovative medical devices.Key ResponsibilitiesExecute biostatistical aspects of research and...