SRQ124447 - Q&R Compliance Manager (RM Carla) 353018

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Q&R Compliance Manager

Your challenge
To assure 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, clinical, service and support teams. Supports organization to work compliant in a lean way.
Your responsibilities
•Instruct, coach and facilitate project team’s w.r.t Innovation Site Eindhoven-Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).
•Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
•Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
•Create quality function deliverables as per Innovation Site Eindhoven –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
•Review Requirements Management process and outcome.
•Reviews Product Verification and Validation.
•Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
•Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
•Ensures timely execution and required communications and escalation.
Your team
You will be part of the Q&R team consisting of approximately 30 team members working for the businesses- Mother &Child Care, Skin Care, Connected Health 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.
Our offer
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
We are looking for
•Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
•Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
•Preferably experience in a medical device industry.
•Proven ability to successfully incorporate and manage stakeholder needs throughout a project •Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
•Both detail oriented and able to see big picture

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