18 annunci per il ruolo di manufacturing process - trezzo sull'adda, lom (recruiting in corso)

Risk Manager
Sinclair —Monza, Lombardia
- Gestionale
- Ingegneria
- Inglese
PVD - Process engineer - Internship
STMicroelectronics —Agrate Brianza, Lombardia
- Inglese
- Microsoft Office
- Tirocinio formativo/stage
12 giorni
QHSE Specialist (Open also to Protected Categories, law 68/99)
Thales —Monza, Lombardia
- Tempo pieno
- Ingegneria
- Laurea triennale
- Produzione
Technical Consultant CAD processes
Dassault Systèmes —Segrate, Lombardia
- 55.000 € - 75.000 € all'anno
- Gestionale
- Vendite
- CAD
Manufacturing Engineering Technician C2V
Technoprobe —Cernusco Lombardone, Lombardia
- 25.000 € - 30.000 € all'anno
- Microsoft Excel
- Maturità
- Produzione
Junior Environmental Consultant (f/m/d)
Jacobs —Cologno Monzese, Lombardia
- 26.600 € - 33.200 € all'anno
- CAD
- Inglese
- Microsoft Office
12 giorni
Implementation Project Manager (eQMS)
Eurofins Italy BioPharma Product Testing —Vimodrone, Lombardia
- 25.000 € - 34.000 € all'anno
- Tempo pieno
- Inglese
Candidatura rapida
SIMULIA Multibody/Motion Engineer
SIMULIA —Segrate, Lombardia
- 43.000 € - 47.000 € all'anno
- Dottorato di ricerca
- Ingegneria
- Inglese
MEMS Technology Platform Development Eng
STMicroelectronics —Agrate Brianza, Lombardia
- 42.000 € - 50.000 € all'anno
- Ingegneria
- Inglese
- Laurea magistrale
Automation & RPA Engineer (IT Solutions)
Eurofins Italy BioPharma Product Testing —Vimodrone, Lombardia
- 25.000 € - 34.000 € all'anno
- Tempo pieno
- Inglese
- Python
Candidatura rapida
Digital & IT Analyst
Parker Hannifin Corporation —Cinisello Balsamo, Lombardia
- Tempo pieno
- Inglese
- Microsoft Office
- SQL
15 ore
Construction Engineer - Electrical specialist
STMicroelectronics —Agrate Brianza, Lombardia
- 38.000 € - 45.000 € all'anno
- AutoCAD
- Inglese
- Laurea magistrale
Finance & Productivity Analyst
Thermo Fisher Scientific —Monza, Lombardia
- Tempo pieno
- Microsoft Powerpoint
- Microsoft Excel
- Ingegneria
SIMULIA Structural Engineer
SIMULIA —Segrate, Lombardia
- 43.000 € - 47.000 € all'anno
- Dottorato di ricerca
- CAD
- Ingegneria
Jr Pre-Sales Engineer – Mobile Construction Sector - Graduate Specialist Program (m/f/d)
Rexroth —Cernusco sul Naviglio, Lombardia
- 31 € - 34 € all'anno
- Tempo pieno
- Vendite
- Inglese
- Laurea magistrale
Candidatura rapida
Mechanical Engineer
Cavotec SA —Nova Milanese, Lombardia
- 35.000 € - 50.000 € all'anno
- Remoto
- CAD
- Sistemi ERP
- Inglese
- Parcheggio libero
Quality Specialist - Nuclear Automation
ABB S.p.A. —Sesto San Giovanni, Lombardia
- Da 39.000 € all'anno
- Gestionale
- Ingegneria
- Inglese
Candidatura rapida
11 giorni
Global Welding Software Sales Manager
ABB Robotics Italy S.p.A. —Sesto San Giovanni, Lombardia
- Vendite
- Ingegneria
- Inglese
Candidatura rapida
5 giorni

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Risk Manager

Sinclair -
Monza, Lombardia

Candidati adesso

Dettagli della posizione

Tempo indeterminato

Qualifiche

Gestionale
Ingegneria
Inglese
Laurea magistrale
Capacità di presentazione
Gestione del rischio
Usabilità

Descrizione completa della posizione

Sinclair is Hiring!

Join Our Team as a Risk Manager

We are currently recruiting for Risk Manager. The Risk Manager will have reports into the R&D Director to contribute directly to meeting regulatory submission, launch timelines of medical devices and aesthetic products as well as regular review activities.

The Risk Manager is responsible to maintain risk management activities for legacy devices and to support new product development activities.

The ideal candidate will have:

Minimum of 2 years of experience in regulated medical device industry
Knowledge of usability engineering or human factors engineering for medical devices
Knowledge in usage of risk assessment methods
Masters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)
English: Fluent

About Sinclair Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide. This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

Sinclair Values: Act with Integrity Consistently doing the right thing even when it’s the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleagues

What You'll Be Doing:

Lead and coordinate all risk management activities according to ISO 14971, ISO 13485, MDR and annex XVI.
Plan, prepare and perform risk management for medical devices and aesthetic products according to project phases following all relevant internal procedures, processes, and external requirements for development products.
Represent Risk Management on assigned development projects.
Establish risk acceptance criteria for individual residual risks and the overall residual risk for specific devices in development and for legacy devices
Maintain a close link to the Human Factors / Usability Engineering process to meet the needs and ensure the safety of all users and patients.
Support creation of device design specifications to ensure that risk control measures are appropriate.
Monitor that risk control measures have been implemented, verified, and validated.
Maintain knowledge of current Company policies, standards and guidelines as well as industry practices, regulatory requirements, and other relevant information.
Ensure harmonized approaches to risk management across projects. Communicate with Research and Development team members on other projects to share lessons learned and ensure use of common tools and ideas within the team.
Ensure that the risk management process incorporates all relevant data from the Design Authorities e.g., Design FMEAs, Security Risk Analysis, Use-related risk analysis, formative human factors evaluations and human factors validation studies.
Ensure that risk management reports are prepared in a timely manner and in accordance with ISO 14971 and applicable Company SOPs and guidelines and are adequate for inspection by notified bodies and other relevant authorities.
Present project-specific risk management activities at regulatory body inspections and internal audits.
Work cross-functionally with other global functions: e.g., Global Marketing, Global Regulatory Affairs, Clinical Affairs and Manufacturing.
Support a good link between risk management during development and risk management for marketed products.
Ensure that all hazards associated with a medical device and aesthetic products are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.
Assures that Company quality and compliance standards and applicable government regulations are met by means of independent risk management for medical devices under development.
Performs risk management in medical device and aesthetic projects and assists medical device sites in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
Has overall responsibility that medical devices and aesthetic products are designed to be safe, effective and in compliance with the applicable regulations worldwide.

Your skills and experience Essential:

Minimum of 2 years of experience in regulated medical device industry
Knowledge of usability engineering or human factors engineering for medical devices
Knowledge in usage of risk assessment methods
Masters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)
English: Fluent

Desirable:

Experience in the manufacture of Medical Devices
Good knowledge of medical standards, e.g.: ISO 14971:2019 ISO 13485:2016 MDR Annex XVI (MDR)

What We're Looking For:

Role competencies:

Experience in performing risk management for medical devices
A general understanding of the potential sources of risk and how to manage

· Flexibility in approach and ability to adapt to changing circumstances and priorities when required · Highly self-responsible, goal-oriented and proactive, with ability to complete projects and meet deadlines

Excellent communication and presentation skills, to inform and persuade both in speaking and in writing

General competencies:

Excellent team player, decision maker and problem-solver

· Patient and understanding · High level of attention to detail

Strong interpersonal skills and sensitivity
Empathetic

The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

This is an exciting opportunity to join a successful company, with big ambitions for the future. If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

Please note if we receive a high volume of applications, we may close the role before the closing date noted. By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad. Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies.

Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void

Candidati adesso

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