Speaking Dutch Quality Assurance Engineer

North Brabant  ‐ Onsite
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Description

Proteus Europe is searching for a Quality Assurance Engineer speaking Dutch available for a long term contract in the Netherlands

Our Client:-
Are a globally respected consultancy company who operate at the highest levels of service and successful delivery. They have a track record for delivering projects on time with customer satisfaction as their first priority. They set high standards and as such working with them also reflects on your high standards of service and programming ability.

Your New role:-

Your Responsibilities
In this role as Software Quality Assurance Engineer you will be responsible for the following:
o Enforce policies and procedures for System Life Cycle control for use in Healthcare across all automated processes that drive, interface with, and provide data for the Quality System.
o Support development of the validation strategy and the validation effort from planning to retirement of SAP based QMS applications and tools including interfaces to and from the system.
o Provide subject matter expertise during regulatory and partner inspection.
o Provide software quality assurance support in design and development of software solutions, and facilitate the application of controls and risk management by reviewing and approving IT change-control requests submitted by cross-functional project teams to assess potential quality system impact.
o Ensure that system development projects and changes to existing systems are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.
o Work alongside other validation professionals to gather data, plan activities, and obtain reviews and approvals of documentation including approving documentation with respect to software development life cycle policies and procedures.
o Assist in developing user, functional and technical requirements for IT systems.
o Provide guidance and support to personnel in their validation efforts, to ensure compliance.
o Provide GxP-related quality assurance oversight, with an emphasis on software validation.
o Track system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
o Represent Quality and Regulatory Compliance and Control on cross-functional teams in support of SDLM activities.
o Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.

We are looking for:
IT Software Development Experience Preferred
Must have 5+ years of experience as a Software Quality Assurance Engineer, and 10+ of experience in Software Life Cycle Process Development
Understanding of transition from a traditional SAP implementation to cloud is preferred (SAP HANA Cloud Platform), as the Overall program is the simplification and standardization of an ERP backbone based on SAP.
Must have experience in SAP consolidation and Deployment across major world geographic areas as it relates to SQA role and responsibilities.
Must have experience in maintaining an application in a validated state efficiently
Must have 3+ experience in SAP validation planning and execution.
Must have experience in validating and maintaining a set of applications on an ERP backbone in a validated state, using SolMan (and ChaRM) for Change Control Management and Validation Deliverables.
Good communication skills in a must, and ability to describe validation requirements clearly, concisely and in a convincing manner.
Demonstrated ability to interact and communicate (both oral and written) with junior project team/organizational members, business leaders and senior executives.
Experience as an SAP Project manager is a plus but not required
Engineering degree in computer Science is preferred
Commuting distance to site in Eindhoven, NL.
Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
Expertise in IT protocols related to software/hardware validation, information security, data life cycle management
Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
Ability to apply current inspectional techniques to project documentation during the system life cycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
Effective judgment and decision making skills, typically made under stressful situations
Competency in project management and the execution of multiple projects

Your Skills and experience:-

Essential Skills:-
IT Software Development Experience Preferred
Must have 5+ years of experience as a Software Quality Assurance Engineer, and 10+ of experience in Software Life Cycle Process Development
Understanding of transition from a traditional SAP implementation to cloud is preferred (SAP HANA Cloud Platform), as the Overall program is the simplification and standardization of an ERP backbone based on SAP.
Must have experience in SAP consolidation and Deployment across major world geographic areas as it relates to SQA role and responsibilities.
Must have experience in maintaining an application in a validated state efficiently
Must have 3+ experience in SAP validation planning and execution.
Must have experience in validating and maintaining a set of applications on an ERP backbone in a validated state, using SolMan (and ChaRM) for Change Control Management and Validation Deliverables.
Good communication skills in a must, and ability to describe validation requirements clearly, concisely and in a convincing manner.
Demonstrated ability to interact and communicate (both oral and written) with junior project team/organizational members, business leaders and senior executives.
Experience as an SAP Project manager is a plus but not required
Engineering degree in computer Science is preferred
Commuting distance to site in Eindhoven, NL.
Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
Expertise in IT protocols related to software/hardware validation, information security, data life cycle management
Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
Ability to apply current inspectional techniques to project documentation during the system life cycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
Effective judgment and decision making skills, typically made under stressful situations

Proteus Europe operates in partnership with our candidates by building strong and lasting relationships at all levels.

If you apply for this role, we will:

- Contact you within one week to discuss your current situation and suitability for this role.
- Keep searching for other suitable positions should this role not be right for you.
- Keep you informed at every stage of the recruitment process.
- Actively follow up with our client on your behalf to gain useful feedback throughout the process.

If you are looking for a new role, but this role isn't quite right for you, please contact us in confidence for a discussion about how we can help you.

Start date
ASAP
Duration
9 months
From
PROTEUS EUROPE
Published at
04.04.2017
Project ID:
1318773
Contract type
Freelance
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