€ 60,000 - € 70,000
Detachering via YER
Medical & Health
Over deze vacature
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.
This role provides subject matter expertise with respect to the compliance and control of regulated tools used in the Quality Systems. The scope of this role extends from PH Q&R specific tools to those tools controlled by the PH business units that have implications in their respective quality systems. Support in this manner is determined by organizational demand and location of the tool with regards to the particular quality system(s) it is supporting.
In this role as Software Quality Assurance Engineer you will be responsible for the following:
- Enforce policies and procedures for system development lifecycle management control for use in Philips across all automated processes that drive, interface with, and provide data for the quality system
- Support development of the validation strategy and the validation effort from planning to retirement of quality relevant systems and tools including interfaces to and from the system.
- Support regulatory and internal audits. Provide subject matter expertise during regulatory and partner inspection
- 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
- Ensure that system development projects and changes to existing systems are conducted in compliance with the FDA quality system regulation and medical device directives
- 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 lifecycle policies and procedures
- Assist in developing user, functional and technical requirements for IT systems
- Provide guidance and support to personnel in their validation efforts, to ensure compliance
- Provide GxP-related quality assurance oversight, with an emphasis on software validation
- 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
- Represent quality & regulatory compliance and control on cross-functional teams in support of SDLM activities
- Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
You will be part of the Q&R team that consists of approximately 40 team members working for the businesses- Mother & Child Care, Skin Care, Health Measuring Devices & Pain Relief reporting to the QAM Group lead. You will be based in Eindhoven, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
We are looking for
- Minimum 7-10 years’ experience in validation of computer systems and systems security and control including supervision of a technical professional staff
- Experience in working at a disciplined regulated industry with the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
- Minimum of 7 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