EU MDR - Software Quality Engineer
Can you be independent and take a pro-active, constructive and immediate approach to ensure compliance with Quality Systems and regulations?
In this role, you will be part of the Quality & Regulatory team working on a project with focus on validation activities to improve critical processes and tools incorporating initiatives and changes for meeting regulation requirements and improving compliance.
This Transformation journey is exciting and challenging, you will have the opportunity to contribute in a true transformation in critical areas within an international company. At this moment there are few QMS areas and new regulations which require project based approach and time sensitive hands on work. We are looking to strengthen the team to successfully manage this transformation. We are looking for an expert in software quality engineering area with project management skills to join our efforts.
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support functional teams, peer group managers in different layers / departments of the company enabling functions in this transformation. This involves being a confident advisor on approval, regulatory compliance and quality management system on validation of software systems, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
• End to end approach for defining the scope of the work needed, alignment with global teams working on the same project in different areas of business.
• Ensure plans are realized, drive and implement defined actions timely in an effective manner.
• Review and approval of validation deliverables, including but not limited to tool classification / risk analysis, Validation Plan, User Requirements Specification, Test protocols and Reports, etc.
• Performing testing of software tools and applications for local implementation.
• Coordinate with E2E validation team and local QMS stakeholders and approvers. Report on status to Q&R, Business and Project management.
• Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance with QMS, prior to issuance.
• Ensure documentation of SW validation activities and results for all phases of the software system Life cycle.
At Philips, we strive to make the world healthier and more sustainable through innovation.
Within Philips Image Guided Therapy solutions for minimally invasive therapy, Philips is bringing tremendous change to the way care is being delivered to patients.
Quality & Regulatory (Q&R) works with businesses & markets to improve product quality, speed up approval timelines and ensure we are fully compliant. Our aim is to achieve timely releases of products with high quality and outstanding reliability
We are looking for
To be suitable for this role you are graduated (bachelor or university degree) in technical or engineering or/and IT related field(s). You have excellent interpersonal and communication skills.
Furthermore, you have:
• A Masters or Bachelor Degree in Engineering.
• Good understanding of Change Management theory, techniques and how to implement them into a project. Understands how to address different types of resistance to change.
• Able to coordinate between different functions and ensure integrated plan will be executed.
• Experience in a large multinational company.
• Fluent in English language.
• Can operate both on strategical as tactical level w.r.t. project approach, priorities, risk management etc.
• Proactive and able to act on own initiative
• Excellent organizational skills to manage and track deliverables
• hands-on, quality minded and customer focused
• 3-5 years of experience with computer system validation.
• Knowledgeable of 21CFR part 820 /11, IEC62304, ISO13485, ISO14971, EU MDR, V-model methodology and guidance documents: GPSV / AAMI TIR36.