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Quality Project Leader
PhilipsHong Kong, Hong Kong, Hong Kong6 days ago
Job descriptionInstruct, coach and facilitate project team’s w.r.t Quality Management System (Procedures / Policies / Guidelines / tools / training, etc.). Instruct, coach and facilitate project teams on relevant product standards (IEC60335 / IEC62368 / IEC60601 / 21) Ensure product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements. Ensure execution of Product Quality test plans during the lifecycle of the product covering all aspects. (Product verification, early market feedback, ongoing reliability testing, etc.). Facilitate Risk Management activities according to ISO 14971 : 2019 (quality of RMM, UFMEA, DFMEA, PFMEA, etc.). Can Lead quality related problem solving and root cause analysis during design and manufacturing. Leads 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. Drives and initiates improvements in new / current project based on learnings / feedback from earlier projects / market. (both Safety and Quality feedback) Uses 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. Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone of product development process. The Q&R team working for the businesses of Philips Avent - Mother & Childcare, reporting to the R&D Quality Manager in Hong Kong. You will be based in Shenzhen, and you will work in project teams with coordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips. Bachelor's degree or above Minimum 5 years working experience, related to medical device and consumer electronics product industry is definitely advantage. Understanding of Design Controls and FDA 21CFR Applied knowledge of appropriate global consumer product regulations, requirements, and standards such as IEC60335, IEC62368, IEC60601, ISO 9001, ISO13485. Qualification / Training in Design for Six Sigma and Statistics. Experienced in using tools and methodologies such as Design-FMEA, Process-FMEA; CTQ flow down; SPC, etc. Proven ability to successfully incorporate and manage stakeholder needs throughout a project. Communicate globally, across teams and programs, from senior executives to administrative support personnel and external parties. Composure, conflict management, timely decision making, listening skills, self-motivation, and perseverance are all requirements of this position. Able to thrive in a fast-paced, team-oriented, new product development environment. Detail oriented and able to see the big picture.
JOB DESCRIPTION
Job Title
Quality Project Leader
Job Description
In this role, you have the opportunity to
- Join one of our key growth areas, Mother & Childcare category (Philips Avent). On the basis of his / her professional specialization at academic level, makes a fundamental contribution to the innovation of products. You will be working for our Smart Parenting sub-business. Being a part of Mother & Childcare Q&R team, you will assure the Quality and Safety of Innovative products in a dynamic environment and 3rd party’s manufacturers.
- Key challenges include risk management, problem solving, compliance management, design quality verification activities and coordination of quality activities with Engineering, Procurement, Manufacturing and Supply Quality. You will support organization to work compliant in a lean way.
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Project • Hong Kong, Hong Kong, Hong Kong
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