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Design Quality Engineer
Eingestellt von Experis AG
Gesuchte Skills: Design, Engineer, Engineering
Projektbeschreibung
DESIGN QUALITY ENGINEER
Experis IT is Europe's leading IT&T recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.
On behalf of our client, one of the WORLD'S BIGGEST MEDICAL DEVICE COMPANIES, located close to Solothurn we are looking for a DESIGN QUALITY ENGINEER
This is a CONTRACTING position from the SECOND OF MAY 2018 UNTIL THE 31ST OF DECEMBER 2018.
You will be part of an exciting upcoming project regarding the new EU Medical Device Regulations (EU MDR) which state that all medical device companies must demonstrate and maintain compliance in accordance to these regulations. You will be a Design Quality team member focused on life cycle management activities.
YOUR TASKS:
- Enhancing the Design Control and Risk Management processes to better reflect the state of the art practices & drive continuous improvement
- Applying statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes, perform Gage R&R studies
- Conduct and lead design verification, validation activities, failure mode effects and analysis
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
- Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
- Additional duties as assigned
WHAT YOU BRING TO THE TABLE:
- BACHELOR's degree
- 7+ YEARS OF EXPERIENCE
- Working knowledge of DESIGN CONTROLS, GMPS, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 AND ISO14971 QUALITY REQUIREMENTS
- Experience in an MEDICAL DEVICE REGULATED ENVIRONMENT
- ENGLISH language proficiency
- Strong MS Office Skills
IT WOULD BE A PLUS IF YOU ALSO HAVE:
- Previous Quality Engineering experience
- German
LOCATION: Baselland
If you are a result oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application!
If you aren't sure whether you should apply or have any questions, please call Nastasia Whyte.
Experis IT is Europe's leading IT&T recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.
On behalf of our client, one of the WORLD'S BIGGEST MEDICAL DEVICE COMPANIES, located close to Solothurn we are looking for a DESIGN QUALITY ENGINEER
This is a CONTRACTING position from the SECOND OF MAY 2018 UNTIL THE 31ST OF DECEMBER 2018.
You will be part of an exciting upcoming project regarding the new EU Medical Device Regulations (EU MDR) which state that all medical device companies must demonstrate and maintain compliance in accordance to these regulations. You will be a Design Quality team member focused on life cycle management activities.
YOUR TASKS:
- Enhancing the Design Control and Risk Management processes to better reflect the state of the art practices & drive continuous improvement
- Applying statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes, perform Gage R&R studies
- Conduct and lead design verification, validation activities, failure mode effects and analysis
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
- Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
- Additional duties as assigned
WHAT YOU BRING TO THE TABLE:
- BACHELOR's degree
- 7+ YEARS OF EXPERIENCE
- Working knowledge of DESIGN CONTROLS, GMPS, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 AND ISO14971 QUALITY REQUIREMENTS
- Experience in an MEDICAL DEVICE REGULATED ENVIRONMENT
- ENGLISH language proficiency
- Strong MS Office Skills
IT WOULD BE A PLUS IF YOU ALSO HAVE:
- Previous Quality Engineering experience
- German
LOCATION: Baselland
If you are a result oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application!
If you aren't sure whether you should apply or have any questions, please call Nastasia Whyte.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik