vacature overig

Software Quality Assurance Engineer

Derks & Derks Detachering

A temporary position as a Software Engineer for the Quality system until the end of the year at a global healthcare company

Offer
  • a challenging job within a global healthcare company
  • an operational role within an international environment
  • a temporary contract until the end of the year
Organisation

Our client is international active in the healthcare industry. They produce and sell their products on the international market. They are always looking for new innovative medical device products by investing in research and development. With this investments they hope to stay on top of the market. They design the product through the eyes of the end user combined with an appealing design. The organisation is always looking for improvement of their processes, therefore they like to get in touch with a Software Quality Assurance Engineer.

Position

The Software Quality Assurance Engineer role is a vital organizational component ensuring regulated automated tools used in the Quality System are appropriately validated and controlled through their life cycle from development, deployment, change control and retirement. This includes ensuring project teams adhere to processes and control mechanisms for software, hardware, data and relevant security to meet regulatory requirements.

In this role it is your responsibility to 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. You will support development of the validation strategy and the validation effort from planning to retirement of Q&R systems and tools including interfaces to and from the system. You will also give support to regulatory and internal audits just like providing subject matter expertise during regulatory and partner inspection. You will 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. You ensure that system development projects and changes to existing systems are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives. It is a challenging job with a wide responsibility to the Quality System. You will report to the manager of the department.

Profile
  • at least 7 years of experience in validation of computer systems and systems security and control including supervision of a technical professional staff
  • experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
  • multiple years of experience with computerized systems implementations, comprised of multiple application types, in a regulated environment
  • demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
  • expertise in IT protocols related to software/hardware validation, information security, data lifecycle 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 lifecycle 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
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-149-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra at number +31 (0)33 472 80 87. An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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