- Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, Edwards Lifesciences SOPs and Good Documentation Practices (GDP) Utilize test equipment to verify equipment parameters, process outputs or product outputs. Anticipate risks of execution and put mitigations in place so audit review requirements are met. Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria. Work with cross-functional partners to implement comprehensive preventative maintenance work instruction as well as revalidation requirements. Write Validation Plans for projects that require multiple validations and create timeline for validation.
- Provide daily direction and guidance to manufacturing processes and personnel.
- Review and disposition Non-conformance reports where needed. Assist in Root Cause analysis in order to determine corrective and preventive action activities
- Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions and Device Records
- Evaluate risk, manage risk assessment activities and create associated documentation.
- Investigate and implement solutions to audit findings.
- Lead process improvement projects as part of life cycle approach.
- Other incidental duties assigned by Leadership
- Basic understanding of statistical techniques.
- Manufacturing Engineering and/or Process Validation background preferred
- Proven ability to apply Engineering/Scientific theory
- Strong problem-solving, organizational, analytical and critical thinking skills
- Excellent verbal and written communication skills in English.
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- The Validation Engineer will need to be highly flexible and assume multiple engineering roles. As the volume of work expands in Israel, increased specialization of engineering positions will be more practical.
- This engineer will be expected to work closely with coaches and peers in Irvine, to enable the flexible nature of this job.
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
-
Engineer I, Quality Validation
3 settimane fa
Edwards Lifesciences Bardi, ItaliaEngineer I, Quality Validation (Laboratories), Critical Care (Temporary) type Full time Location Dominican Republic, Nave 25, Merengue Apply knowledge of engineering principles and methods to ensure compliance in product and process development, validations and process optimizati ...
-
Engineer I, Quality Validation
1 settimana fa
Edwards Lifesciences Bardi, ItaliaEngineer I, Quality Validation (Laboratories), Critical Care (Temporary) type Full time Location Dominican Republic, Nave 25, Merengue Apply knowledge of engineering principles and methods to ensure compliance in product and process development, validations and process optimizati ...
-
Business Analyst Emea Latam
2 settimane fa
ZOLL LifeVest Piacenza, Italia**Location: Piacenza, Italy**: · **Resuscitation**: · ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand ...
-
Plant Controlling Manager
2 settimane fa
Emerson Fiorenzuola d'Arda, Italia**Job Summary**: · **2. Responsibilities** · - Monthly forecast cycle: actual analysis, bottom-up forecast and stakeholder communication. · - Month-end closing activities, such as: account reconciliation, journal entry preparation and management reporting. · - Ensure financial pr ...
-
Process Engineer Injection Molding
3 giorni fa
Antal International Network Bardi, ItaliaProvides engineering support, including equipment/tools troubleshooting, training, upgrades, efficiency and safety improvements, etc. Through the use of Data, identifies and implements process parameters setup and changes that will improve quality and productivity Supports new pr ...
-
Site Validation Representative
2 settimane fa
Takeda Bardi, ItaliaBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I submi ...
-
Production Technician
2 settimane fa
Tn Italy Bardi, Italiacol-wideJob Description:EFI is looking for a Mechanical Production Technician to join our InkJet Business Unit in Italy - Comun Nuovo (BG).In this role, your primary task(s) of assembling and testing the validation of EFI digital inkjet printers in a standardized environment whil ...
-
Driver / Data Collector In Brescia, Italy
3 giorni fa
Terry Soot Mg Bardi, ItaliaCompany description Terry Soot Management Group (TSMG) is a field data collection company founded in 2017 in Europe. We collect data where automation is not possible. We count features, take pictures, make videos, record speech, and scan areas for every detail you need to make mo ...
-
Process Automation Engineer
2 settimane fa
Antal International Network Bardi, ItaliaProvides engineering support, including equipment/tools troubleshooting, training, upgrades, efficiency and safety improvements, etc.Through the use of data, identifies and implements process parameters setup and changes that will improve quality and productivitySupports new prod ...
-
Educatore
2 settimane fa
Adecco Italia Spa Bardi, ItaliaJob summary · Educator opportunity in BozzoloCreate and implement customized educational programs for the elderlyPromote the physical, mental, and social well-being of the guests · Job seniority: entry level · Responsibilities · • Create and implement personalized educational pro ...
-
R&D Electromechanical Engineer
3 settimane fa
Abb Schweiz Ag Bardi, ItaliaR&D Electromechanical EngineerTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensio ...
-
R&D Electromechanical Engineer
1 settimana fa
Abb Schweiz Ag Bardi, ItaliaR&D Electromechanical EngineerTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future.At ABB, we have the clear goal of driving diversity and inclusion across all dimension ...
-
Machine Learning Engineer Ai Center
3 giorni fa
Nlp People Bardi, ItaliaThe Machine Learning Engineer has experience in machine learning and deep learning applied to structured and unstructured medical data. Your main contribution will be focused on developing models to answer clinical questions with evidence in a R&D setting using data from the elec ...
-
Quality Control Technician
4 giorni fa
Abb Schweiz Ag Bardi, ItaliaQuality Control TechnicianTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future.At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: g ...
-
R&D Associate Engineer
3 settimane fa
Abb Schweiz Ag Bardi, ItaliaR&D Associate EngineerTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future.At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gende ...
-
Quality Control Technician
3 giorni fa
Abb Schweiz Ag Bardi, ItaliaQuality Control TechnicianTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future.At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: g ...
-
Senior Supplier Quality Engineer
2 settimane fa
Mozarc Medical Bardi, ItaliaThursday, December 7, 2023 · About Mozarc Medical · At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the wor ...
-
Seeds Production Agronomist
2 settimane fa
Syngenta Seeds Bardi, ItaliaJob Description Role purpose You will be responsible for corn field production and growers' follow up in Po Valley Growing Area , from field planning to harvest (according to the country SPP and local split); delivering the right quantity and quality requested by Syngenta. Accoun ...
-
Analyst, Quality Engineering
2 settimane fa
Sc Johnson Professional Bardi, ItaliaANALYST, Quality Engineering · • Location: Arese - Italia · • Function: Quality EngineeringOverview:About the role You will manage regional quality engineering tasks concerning production of finished goods at EMEA 3PMs and EMEA suppliers to ensure quality is driven into the produ ...
-
Analyst, Quality Engineering
2 settimane fa
Tn Italy Bardi, Italiacol-wideJob Description:ANALYST, Quality Engineering · • Location: Arese - Italia · • Function: Quality EngineeringOverview:About the roleYou will manage regional quality engineering tasks concerning production of finished goods at EMEA 3PMs and EMEA suppliers to ensure quality i ...
Engineer I, Quality Validation - Bardi, Italia - Edwards Lifesciences
Descrizione
Engineer I, Quality Validation (Laboratories), Critical Care (Temporary)type Full timeLocation Dominican Republic, Nave 25, MerengueApply knowledge of engineering principles and methods to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement for Class III medical devices for the Cardioband operation.
Key Responsibilities:
Education and Experience:
Bachelor's Degree in in Engineering or related field , at least 1 year years experience of validation within medical device or pharma industry, or related experience, required
Additional Skills:
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease and critical care monitoringWhat we offerDiversity, inclusion & belonging Find out more > Find out more > Awards & Recognition Find out more > Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
#J-18808-Ljbffr
