Quality Project Lead
- Acting as a single point of contact (person assigned to project team) responsible of Post Market Surveillance activities, by collect and perform data analysis to determine product performance in the field.
- Manage/support the activities for the design changes (MLD -Modify Launched Device) and sustaining activities specific to the product family in alignment with quality and compliance standards
- Leading quality related problem solving and root cause analysis during modification of design and manufacturing to drive and initiate improvements in new/ current project based on learnings/ feedback from earlier projects/ market. (both Safety and Quality feedback)
Using post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
- Instructing, coaching and facilitating project team's w.r.t Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.) ensuring compliance to quality system requirements, regulations and standards in the designated area of responsibility
Instruct, coach and facilitate project teams on relevant product standards (21 CFR820/ISO9001/ISO13485/IEC60335/IEC60601/, etc.)
- Ensuring execution of Product Quality test plans during the lifecycle of the product covering all aspects. (Product verification, early market feedback, ongoing reliability testing, etc.).
- Ensuring regular communication on Quality status, compliance status, field call rate throughout the project execution within the project team and stakeholders.
- Leading all product safety/compliance related activities to ensure that the regulations and policies are fully and timely available and interpreted, products comply with all regulatory requirements and Philips policies and incidents are handled according to corresponding product safety/compliance incident handling process including review and decision making on product safety/compliance related escalations
- Ensuring Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
- Ensuring timely execution and required communications and escalation.