Details of the project:
1.1 General Description
It is to maximize the Supplier Engineering
(SE) team’s capacity to support Suzhou Philips Blue Dragon project. SE team is
looking for a service solution to work with R&D and procurement to implement advanced product quality planning (APQP) including special process validation PV (IQ/ OQ/ PQ/TMV) on purchased parts. It is expected the partner can independently lead APQP and PV end to end to ensure on-time delivery to project schedule with high-quality assurance to meet medical device regulation
requirements CFR820, ISO13485. The activities will extend over 12 months with
about 2 competent people or equivalent workforce, the supplier assists Philips
in hiring people, the supplier shall manage the team to deliver results, major workplace in Philips Healthcare Suzhou, and part-time work at a supplier
location in China. The people recruited, under Philips system, work for Philips. All quality activities are carried out under QMS-0007. Regarding the training and management of personnel, they are all carried out within Philips system.
The partner is expected to be familiar with welding, soldering, crimping, injection moulding, plating, casting, and painting and be capable of writing technical documents in English; The service requires delivery on time on quality referring target setting in section of .
1.2 Project objective
PV
o Train supplier and 100% complete PV before the timeline.·
APQP
o Finish APQP before the timeline.
o Develop supplier’s APQP and PV work to ensure delivery on time on quality
o Deliverables requirement
u Written
technical documents in English. No written complaint from stakeholders in terms of deliverables' quality and timeliness. Quality means fully complied with the procedures, instruction, and training material (in Philips University and TEDS) without deviation unless agreed by Philips.
u Delivery and
quality will be oversighted by Philips SE following QMS requirements of QMS0007 PEPF16.2.19.1 Perform Advanced Product Quality Plan_APQP_2002001015, External Process Validation and Sampling Guideline_2002000735 and GDP.