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Over de functie
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.
• Independently works to deploy common approaches and working methods to drive ‘’One Philips’’ towards Supply Base in the assigned BG or Market.
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 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 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; CtQ definition, DfSS, SPC, APQP, FMEA, Control plans, etc
At YACHT we will offer you a competitive benefits package in line with the seniority of the position.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Sciences industry.
You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Philips is driven by their mission to improve the lives of 3 billion people per year by 2025, and every day they move closer to achieving their goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to their employees who share their passion for improving lives, they are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. They enable their employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
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.