AdresAssure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment. Key challenges include risk management, design quality assurance activities and co-ordination of quality activities with Engineering, Procurement, Manufacturing, Supply Quality, Clinical, Service and Support teams. You will support the organization to be compliant in a lean way.
Managing/supporting the activities for the design changes (MLD -Modify Launched Device) and sustaining activities specific to the product family in alignment with quality and compliance standards
Your role:
Leading quality related problem solving and root cause analysis during modification of design and manufacturing to drive and initiate improvements in new/current project, based on learnings/ feedback from earlier projects/ market (both Safety and Quality feedback)
Using post-market analytics and statistics to report on product quality performance in the field and initiate field actions when required
Reporting trends to identify continuous improvement opportunities and product/process enhancements.
Ensures that processes for specifying and executing field quality analysis actions are adequate to ensure the expectations of all key stakeholders are met.
Delivering key documents such as various Post Market Surveillance reports and facilitates periodic Post Market Surveillance Reviews, ensuring PMS plans are made that include all stages of the life cycle of the product and supports Quality Plan design
Supporting complainant as needed to follow up on and resolve the complaint when needed
Instructing, coaching and facilitating project teams with regard to Quality Management System (Procedures/ Policies/ Guidelines/ tools, etc.), ensuring compliance to quality system requirements, regulations and standards in the designated area of responsibility
Ensuring regular communication on quality status, compliance status, field call rate throughout the project execution within the project team and stakeholders
Leading all product safety/compliance related activities to ensure that the regulations and policies are fully and timely available and interpreted, products comply with all regulatory requirements and Philips policies and incidents are handled according to corresponding product safety/compliance incident handling process (including review and decision making on product safety/compliance related escalations)
Ensuring Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.)
You are a part of
A team of passionate and driven professionals under the business of Grooming & Beauty and reporting to the Business PMS Lead.
You're the right fit if
Bachelor’s and/or Masters degree in an engineering discipline
Robust experience in Quality
Previous experience in Medical device and or applicable consumer product is preferred
Hands-on experience and knowledge in understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO9001, Medical Devices Directive (93/42/EEC, 98/79/EC)) and EU MDR
Problem solving and failure analysis skills and analytical thinking
Self-motivated and a good team player with the ability to work within a cross functional organization
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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Discover our rich and exciting history.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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