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Design Control Engineer (Interim/Freelance)
Eingestellt von Amoria Bond Ltd
Gesuchte Skills: Design, Engineer
Projektbeschreibung
Design control engineer (Interim/Freelance)
KEY WORDS: Design control, Design history file, Product realization, Operational excellence, opex, lean six sigma, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, project, pharma, Blackbelt, Chemical, Chemisch, process industrie, BioAnalysis, IT project manager, IT, Medical Devices, ISO13485, 21 CFR Part 820.30
Contract length:9-12 months
Type:Freelance/interim
Start date: August 2016
Market rate:Competitive
FTE:0,5 FTE average
Interview dates:5, 7 and 8 July 2016
Amoria Bond has partnered up with a leading global Medical Device manufacturer in Belgium. For a project that has its kick off in August 2016 we are looking for a design control engineer with expertise in design history files.
The project is a collaboration of two leading organisations to market a new device, which is currently getting FDA approval.
The design control engineer will join a multidisciplinary project team led by a project manager. You will also team up with the QA department for procedure support.
The design control engineer is responsible for:
*All the design input activities:
-Providing expertise for the collection and the definition of the design input
-Defining the test procedures of the product
-Leading activities related to Risk Analysis
*All the design output activities:
-Follow up on the validation of test procedures
-Support in conducting Simulated user Studies
*The activities related to design review (design input docs, risk analysis design output docs etc.)
*Finalizing the design validation, transfers and changes
*Composing and documenting all activities in a Design History File
The contract will be for a period of 9 to 12 month with an average FTE of 0.5. The hours per week will vary depending on the status of the project.
The design control engineer must:
*Have a BSc. + degree in relevant field
*Have thorough expertise with ISO13485, particularly with subsection Product Realization and 21 CFR Part 820.30 (Design Controls)
*Have multiple years experience as a design control engineer and/or in composing Design History Files
*Strong communication skills in English (Dutch is a bonus)
*Have a flexible mind-set and willing to work flexible hours
If you are interested in this position, please send your CV to (see below) and I'll get in touch with you ASAP.
Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.
KEY WORDS: Design control, Design history file, Product realization, Operational excellence, opex, lean six sigma, ISO, GMP, process validation, Biotechnology, Pharmaceutical, Farmaceutisch, Medical Devices, Food Science, Cosmetic, Clinical Research Organisations, HSE, Chemical, R&D, Medical Writing & Communication, Medical Affairs, Regulatory Projects, PhD, Master, Bachelor, project, pharma, Blackbelt, Chemical, Chemisch, process industrie, BioAnalysis, IT project manager, IT, Medical Devices, ISO13485, 21 CFR Part 820.30
Contract length:9-12 months
Type:Freelance/interim
Start date: August 2016
Market rate:Competitive
FTE:0,5 FTE average
Interview dates:5, 7 and 8 July 2016
Amoria Bond has partnered up with a leading global Medical Device manufacturer in Belgium. For a project that has its kick off in August 2016 we are looking for a design control engineer with expertise in design history files.
The project is a collaboration of two leading organisations to market a new device, which is currently getting FDA approval.
The design control engineer will join a multidisciplinary project team led by a project manager. You will also team up with the QA department for procedure support.
The design control engineer is responsible for:
*All the design input activities:
-Providing expertise for the collection and the definition of the design input
-Defining the test procedures of the product
-Leading activities related to Risk Analysis
*All the design output activities:
-Follow up on the validation of test procedures
-Support in conducting Simulated user Studies
*The activities related to design review (design input docs, risk analysis design output docs etc.)
*Finalizing the design validation, transfers and changes
*Composing and documenting all activities in a Design History File
The contract will be for a period of 9 to 12 month with an average FTE of 0.5. The hours per week will vary depending on the status of the project.
The design control engineer must:
*Have a BSc. + degree in relevant field
*Have thorough expertise with ISO13485, particularly with subsection Product Realization and 21 CFR Part 820.30 (Design Controls)
*Have multiple years experience as a design control engineer and/or in composing Design History Files
*Strong communication skills in English (Dutch is a bonus)
*Have a flexible mind-set and willing to work flexible hours
If you are interested in this position, please send your CV to (see below) and I'll get in touch with you ASAP.
Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik