Philips Systems Design Quality Engineer 

Netherlands, Frisia 

637568833

Your responsibilities

• Instruct, coach and facilitate project team’s w.r.t 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.

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