Philips Process Quality Engineer 

Germany, Hesse 

968726091

You are responsible for

• New Product Introduction projects, Life Cycle Management, and manufacturing location transfer projects to establish a robust manufacturing process to meet regulatory requirements for design transfer, process and tool validation.
• Drive product quality targets such as First Pass Yield (FPY), product and process quality notifications (QN’s)
• Being in lead for establishment and completion of Receiving Inspection Plan (RIP)
• Participate in design transfer and process design activities such as review of Device Master Record, DFMEA, manufacturing design and Process FMEA
• Participation in standardization of processes, PEPF (Philips Excellence Process Framework)
• Mentor and coach managers/engineers on design transfer, process design and the validation life cycle process
• You support the process owner to define the validation life cycle process, by creating the procedure and templates. Once validation state is reached, it is maintained according to change process.
• You ensure that the validation life cycle process meets regulatory and Quality Management System requirements (21CFR part 820.75, 820.70(i), 820.72(a), ISO 13485, and compliance with FDA guidance documents such as GHTF, etc).
• Ensure the content of the process is consistent within the Quality Management System by review & approval
• Ensure that the automated data processing systems and tools are validated against intended use and user need according to GAMP5 methodology
• You accompany internal & external audits related to process validation, such as FDA, 3rd party and notified body audits and ensure initiation and follow up of corrective and preventive actions

You are a part of

You will be a part of the Factory Best organization,which is one of the main Operation sites for Health Systems within Philips. We drive operational excellence and manufacture, refurbish and repair our medical devices & components in a safe, compliant, and effective manner.

To succeed in this role, you should have the following skills and experience

• Bachelor of Science degree in a technical or business discipline
• Minimum 3 years of experience in a medically regulated and technical environment within a medical device company
• Knowledge of manufacturing and design process and process FMEA, preferably experience in design and establishment of manufacturing processes, Design FMEA, DMR, Design for Assembly, manufacturability and testability
• Excellent knowledge of medical device regulations 21CFR FDA parts 820.30(h), 820.75, 820.70(i), 820.72(a), 820.80 and ISO 13485 and guidance documents, knowledge of ISO14971
• Statistical knowledge, particularly Gage R&R ANOVA, Attribute Analysis agreement and process capability such as PpK study, First Pass Yield
• A good communicator on different organizational levels in English
• Strongly preferred: proven experience in multi-site, multi-disciplinary quality organizations

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.