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Over de functie
Quality engineer for manufacturing
In this role, you have the opportunity to be part of the dedicated Quality team for the Factory Best. The Quality department of the factory Best will be reporting into the Q&R function and will have a dotted line to the Factory leader. The Quality department focusses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability.
By joining this organization, you will be part of the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence.
In this role you have the opportunity to be part of the team of Quality engineers
You are responsible for
• Accountable for ensuring full quality and regulatory compliance for his/ her unit(s) (e.g. Building Blocks – BB/Process Product Group – PPG),
• Taking charge and participate in multidisciplinary improvement,
• Proactively participate in daily direction of his/ her units like MRB (Material Review Board), escalations (production stop), PPG’s, supplier meetings, daily commcell,
• Maintaining and improving performance via Quality tools and techniques,
• Ensures site audit readiness and hosts the quality system audits,
• Performs internal audits in the units on applicable procedures, regulations and instructions,
• Proposes corrective measures for the audit findings and follows progress,
• Stimulates and implements tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, PPA,
• DMAIC, problem solving methods, statistical process control, 5S + 1,
• Process, validate and close QN’s (Quality Notifications) in SAP and NC (Non Conformity) documents,
• Reviews and approves DHR (Design History Record) before final release,
• Reviews and approves DMR (Device Master Record) and DHF (Design History File) before release,
• Supports timely and correct closure of CAPA’s and ensures compliancy in his unit,
• Monitoring Quality of incoming goods, and the improvement of those goods.
• Adhere to company procedures and maintain compliance with FDA QSR regulations and ISO 13485:2016 standards.
• Perform other quality related duties as assigned.
• Providing support ensuring external audit readiness and during external audits/inspections
• Defines, establishes, monitors and improves training on internal auditing
You are a part of
In this role, you have the opportunity to be part of the Factory Best organization, which is one of the main Operation sites for Health Systems within Philips. Our Factory Best organization is driving operational excellence and manufactures, refurbishes and repairs our medical devices & components in a safe, compliant, and effective manner. Next to this, the Factory Best team is responsible for the preparation and introduction of changes on products/components/production processes for released products and receiving and implementing manufacturing transfers from Industrialization engineering.
To succeed in this role, you should have the following skills and experience
• HBO level (mechanics or electronics),
• 4+ years within quality assurance or quality control within an operational environment (preferably medical devices, automotive or aerospace),
• Knowledge of tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, problem solving methods, statistical process control, 5S + 1, PPA or APQP, DMAIC,
• Process minded and able to make and optimize procedures and supporting documents,
• Excellent analytical, problem solving and root-cause analysis skills
• Ability to present issues to a management level,
• Excellent communication and reporting skills in Dutch and English.
• Character: people-oriented, no-nonsense, pro-active, make-it-happen mentality, pressure-resistant, able to get things done from people, disciplined.
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.
Why should you join Philips?
We offer projects that really put your skills to the test. Lots of learning opportunities through regular, on-the-job feedback and knowledge exchange with specialists in many different fields. Creative freedom so you can express yourself and apply your expertise in a way that makes an impact. A friendly and collaborative culture that encourages you to contribute to our health tech strategy, making life better for 3 billion lives a year by 2025.
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.
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