- 21 februari 2018
- vacaturenummer: 9050352
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.
• 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.
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
We offer the opportunity to play a leading role in achieving Philips’ ambitions with digital connected products and to truly contribute to the way our innovations improve the health and well-being of our customers. You will work in close cooperation with colleagues from the Electronics department as well as other Software departments across Philips, playing a key role in driving the transition process that will turn Philips into a Digital Systems company. We invite you to be part of a challenging, innovative environment with great opportunities for personal development.
You will be part of the Q&R team consisting of approximately 40 team members working for the businesses- Mother &Child Care, Skin Care, Health Measuring 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.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.
Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.