Systems Compliance Test Engineer (Freelance)
Develop test methods, including equipment requirements, and the execution and reporting of verification tests. You will significantly contribute to the verification of innovative consumer products on safety and quality aspects.
You are responsible for
Managing the interface between Product Development, Safety & Compliance and Regulatory Affairs, with regard to compliance verification related topics relevant for M&CC business and external testing laboratories.
Being the primary contact for System Architects, Quality project leads, Development leads with regard to knowledge support on chemical food contact and biological safety matters.
Support the process of Approbation and Registration to ensure products can be sold to markets in full compliance.
Coordinate with various stakeholders (Development / Compliance) on new tests required.
Coordination with external laboratories on compliance verification testing. Example of activities: compile requirements, define samples quality and quantity, drafting request for quotations (RFQ?s), arrange quotes, critical review of protocols, reports and ultimately driving them to deliver on time and on quality.
Support the Development team in the correct interpretation and implementation of product safety requirements during the life cycle management phase and during new launches of products.
Interact with Development Leads and System Architects to ensure that Product Safety and Regulatory requirements are systematically defined and documented (e.g. via DOORS Or Windchill).
Maintaining an excellent understanding of global regulatory requirements relevant to consumer products and medical devices especially with respect to chemical safety, environmental requirements, and biocompatibility.
Supporting Development Leads during the assessment of relevant regulatory requirements and their potential impact on product under development or during their life cycle.
Supporting / advising with dual sourcing setup for materials, and required regulatory support.
Supporting Development Leads with the updates of Chemical and Biocompatibility Assessments on ongoing basis for new testing completed and documenting per SCNs /other changes.
Works closely with the Regulatory Affairs Specialists to address Safety & Compliance and Regulatory Affairs aspects prior submissions, including responding to requests from Regulators.
You are a part of
The Philips business group Personal Health delivers innovative lifestyle solutions for personal well-being. Our brand promise delivers innovation that matters to you, meaning that our products are caring, innovative & impactful. The sector builds on a deep understanding of people's needs and aspirations to create innovations that help consumers achieve their lifestyle ambitions.
One of the key growth areas is the Mother and Child Care category (Philips Avent), which encompass multiple sub-businesses such as Infant feeding, Comforting, Breast Feeding Solutions.
MCC Innovation site Eindhoven is part of Innovation & Development (I&D) of Philips Personal Health cluster. It focuses on the development of medical and non-medical lifestyle products and solutions. It is responsible for the end-to-end development and realization of new product propositions. The MCC Innovation Site Eindhoven has the ambition to drive business growth by bringing existing, differentiating, new product propositions to market.. As Systems Compliance Test Engineer, you will be part of Test & Verification Team and report to its Group Lead. This team is part of the Innovation & Development team of Mother and Child Care Business The primary working location for this position is the High Tech Campus in Eindhoven.
The role requires to work with external laboratories and internal ones during new product development and also to maintain the ones that are already in the market by ensuring solid execution of product compliances verification activities and their completion in close collaboration with cross-functional teams, and ultimately build up a quality centric product development mindset in the organization. We maintain the Device History File and Device Master Record during the lifecycle phase of products. We optimize and update existing product concepts within cross-functional teams including the marketing/sales and manufacturing organizations. We analyze product issues in the market (root-cause analysis of both production problems and consumer complaints) and take corrective actions if required, by defining and executing changes on existing products. We are responsible to make sure that any design change meets the requirements and we roll out existing products to new markets, while ensuring that documentation shows full compliance.
To succeed in this role, you should have the following skills and experience
Master of Science degree in a technical or biomedical, Material science, discipline.
At least 3 years of relevant working experience in compliance, preferably for medical devices.
Experience with REACH, RoHS, ISO 10993.
Prior experience in Project Management is a strong plus.
We are looking for a team player with a strong customer focus and a quality-mindset.
Able to identify product and users related risks and eager to learn and improve the way of working.
Fluent in English (writing and talking) as well as experience in communicating with a diversity of stakeholders.