Philips Quality Officer Software in Best, Netherlands
The Quality Officer Software (SW) executes accuracy, completeness and compliance of product development required to meet quality system and regulatory requirements in a fast growing organization, operating in an emerging, innovative business. As a QA team member you are engaged in cross-functional activities and as such contribute to the overall success of the Digitral Pathology business and reports to Quality Assurance Manager.
Execute the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality System processes Assess and report adherence to applicable regulations and internal requirements.
Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process Ensure that new software and changes to existing software or infrastructures are validated before approval and use
Ensure documentation of SW validation activities and results for all phases of the software system Life cycle
Provide advice and recommendations to teams in order to help achieve required adherence
Provide advice and recommendations to improve the quality management system
Continued compliance of quality management system.
Digital pathology is a rather new and fast developing field in pathology and is the most innovation in pathology which happened for over the last 30 years. Therefore, new regulations are being set up and new methodologies have to be set up in accordance with the regulations. All this makes working in the group both exciting as well as challenging. It is expected that the QA officer will provide support to the project teams in the development phase in order to assure compliance making the verification and validation process efficient. As a group member the officer should be able to contribute in discussions on all compliance related topics.
Your team consists of relative young professionals and industry experts with a wide variety of backgrounds. Humor, drive, dedication and teamwork are at the heart of the group
Our mission: In a world with increasing challenges for cancer diagnostic procedures and quality of patient care we want to be number one in empowering pathologists with digital pathology solutions so their expertise is supported by the best scanners, IMS, workflow and algorithms available. This helps them work more effectively, leading to higher quality diagnosis and as a result better patient care.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance ?
We are looking for
Bachelors degree in engineering and IT related fields, but any advance degrees are preferable in Quality, Regulatory and Software engineering with an affinity to medical devices
Demonstrated experience with business processes
Practical knowledge of medical European and US standards and regulations.
ISO Standards (i.e., 13485, 14971, 14001)
US, EU & International Medical Device Regulations (e.g., 21 CFR Part 820, MDD)
Ability to deal with changing priorities
Strong communication skills
Pragmatic hands-on mentality
Ability to gain acceptance from others
Can work independently without direct supervision as well as in a team environment