€ 35,000 - € 50,000
Detachering via YER
Manufacturing, Medical & Health
Over deze vacature
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.
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;
- 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.
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.
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.
To succeed in this role, you should have the following skills and experience:
- Bachelor 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.