Quality Engineer - 2 Year FTC - MUNICH GERMANY

45200.00 - 51400.00 GBP Annual + GBP45200 - GBP51400/annum
13 Jun 2017
11 Jul 2017
Contract Type
Full Time
Quality Engineer****2 year Fixed Term Contract**** ???51,000 - ???58,000 per annum****Munich, Germany**I am currently looking for a Quality Engineer for a 2 Year Fixed Term Contract with a Medical Device company based in Munich, Germany.- To be considered for this role you must be fluent in English and at least be able to understand some basic GermanSummary of RoleThe Quality Engineer assures design verification and validation requirements are met for new product introduction and design changes to established products. For new and established products, the Quality Engineer uses a Risk Management approach to feed into design inputs that in turn derive the outputs defining the verification and validation test cases. The Quality Engineer can capture this process in a consolidated traceability matrix that logically shows the relational dependencies of the above. These activities are also an integral part of the preparation and maintenance of design history files which is a key function of this position.The Quality Engineer facilitates the characterization of the product to applicable type testing safety standards such as electrical safety. Supports the application of Danaher Business Systems (DBS) tools throughout the Workflow and Information Technology Solutions (WITS) organization.Specific Responsibilities?? The preparation and ongoing maintenance of design history files for Munich products?? Act as the delegate for the Design Control Manager at product project meetings when required?? Identify sources of risk such as ergonomics, use error and risks associated with product characteristics?? Generation of Risk Management Files?? Assuring verification and validation protocols meet expectations for content such as acceptance criteria and sign off.?? Generation of Traceability matrices that are intuitive in linking test case to requirement.?? Assure software development lifecycle and associated validation requirements are met for the device.
* Defining hardware requirements to maintain equivalence between pre and post design transfer device configurations
Person Spec - Minimum Requirements
* Degree in sciences, life sciences, engineering or quality management or Equivalent education gained through work experiences.

* 3 years+ experience within the regulated environment of in vitro diagnostics or medical devices

* Clean driving record - ability to travel as required.* Fluent in English-written and verbal* Practical experience of ISO9001 and ISO13485* Experience in design verification and validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment* Practical experience with product software verification and validation - development experience is a plus* Knowledge of EN62304, ISO14971, EN62366, EN61010* Computer skills (MS Office products)
If this role is of interest please either apply to this advert or email me on or call me on 0044 (0) (Apply online only).They are looking to hold first stage telephone interview this week.Quality / QA / Medical Devices / ISO13485 / Germany / Munich