€ 50000 - € 60000
Detachering via YER
Medical & Health
Over deze vacature
As a Supplier Quality Engineer you are the interface between the Innovation & Development team at Innovation Site Eindhoven and Manufacturing Suppliers. In this role, you have the opportunity to implement and manage quality engineering, purchasing controls and supplier quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain.
- Partner with R&D, operations and procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers
- Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities
- Ensure raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements
- Drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements
- Ensure compliance to regulatory requirements and procedures for regulated products/processes
- Ensure raw material and component specs and drawings are translated to supplier quality
- Requirements, qualify suppliers, assess metrics of whether supplier products meet quality specifications, and audit suppliers critical to quality processes
- Ensure that validations are completed where specified, and control plans exist to ensure the sustained quality and compliance of supplied raw materials and components
- Ensure correction and prevention activities of suppliers are timely, effective and required communications and escalation
- Create supplier quality function deliverables as per innovation site Eindhoven –quality management system in projects, in life cycle management and in post market surveillance
- Executes SCAR management effective and timely closure and review/risk assessment of QN's and their escalation to SCARs where needed
- Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality
- Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results
- Works independently to deploy common approaches and working methods to drive ‘One Philips’ towards supply base in the assigned BG or market
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
You will be part of the Q&R team consisting of Quality Assurance Managers working for the businesses- Mother and Child Care & Pain Relief reporting to the Q&R Site 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.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
We are looking for
- Bachelor degree in an engineering or science discipline or equivalent
- Current certification with a recognized accreditation body (i.e. RAB- QSA/ IRCA) or a successful completion of ASQ certification as a certified quality engineer (CQE) and certified quality auditor (CQA) or certified biomedical auditor or successful completion of a recognized lead auditor course
- 8 -10 years of total industry experience with 4+ years of related experience in a medical device or regulated industry
- Applied knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO13485, ISO14971, European Medical Devices Regulation, Japanese MHLW Ordinance 169 and ISO9001
- Experience in root cause analysis, corrective and preventive action methods
- Expertise/experience in problem solving with quality tools such as 6-sigma/8-D/CAPA/FMEA/5WHY etc.
- Good Knowledge of production/quality development and control methods like CtQ definition, DfSS, SPC, APQP, FMEA, Control plans, etc.