Philips QA Engineer Operations in Best, Netherlands
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing.
The successful candidate will bring fresh ideas and help lead the Quality Department to a new level of competence and help install a ”can do” mindset with their excellent problem solving ability. There is a need to be able to see the bigger picture and consistently question the status quo. You will work 50% of the time from our Best office and the other 50% from Heerlen. We are looking for an ambitious person who wants to grow to a management position in the future.
Accountable for ensuring full quality and regulatory compliance for his/ her units (e.g. Building Blocks – BB/Process Product Group – PPG)
Taking charge and participate in multidisciplinary (DMAIC) improvement
Proactively participate in daily direction of his/ her units like MRB (Material Review Board), escalations
production stop), PPG’s, supplier meetings, daily communication meeting
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 standards
Perform other quality related duties as assigned.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. The position is within the Quality Assurance Department for Operations and will be a pivotal role in dealing with Suppliers, Supplier Quality, Production, Logistics and Engineering. The team will consist of 12 members in the Netherlands.
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
We are looking for
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations.
Bachelor level (quality, business, mechanics or electronics)
years within quality assurance or quality control within an operational environment (preferably medical devices, automotive or aerospace)
Experience in an operations background is a preference
Knowledge of tools e.g. pareto, 5W/ 2H, Ishikawa, FMEA, 8D, problem solving methods are required
Knowledge of risk analysis is a preference
Complete tasks in a timely matter is a requirement
Statistical process control, 5S + 1, PPA, DMAIC
Process minded and able to make and optimize procedures and supporting documents,
Dynamic, ambitious and good communication skills
Excellent analytical, problem solving and root-cause analysis skills
Ability to present issues to a management level
Excellent communication and reporting skills in English is required (Dutch is preferred)