Philips Senior Manager Product Quality Engineering 

China, Hong Kong, Hong Kong Island 

372903910

Senior Manager, Product Quality Engineering

In this role, you have the opportunity to

• Join one of our key growth areas, Mother & Childcare category (Philips Avent). Based on his/her professional specialization at academic level, makes a fundamental contribution to the innovation of products. You will be working for our Breast Feeding and Healthy Feeding 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, compliance management, design quality assurance activities and coordination of quality activities with Engineering, Procurement, Manufacturing and Supply Quality. You will support the organization to work compliant in a lean way.

You are responsible for

• End to End Quality Engineering responsibility for Class 1 and IIA (class II) medical and non-medical device product development
• Instruct, 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 (IEC60601/ IEC60335/IEC60601/21 /ISO9001/ISO13485, etc.)
• Responsible for hardware design meets quality and compliance standards for every milestone of product development process.
• Responsible for Product Safety Risk Management (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.)
• Create and support quality function deliverables as per Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
• Responsible for creating and 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.).
• 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.
• Can Lead quality related problem solving and root cause analysis during design and manufacturing.
• 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

You are part of

• You will be part of the Q&R team working for the businesses of Philips Avent - Mother &Childcare, reporting to the Safety, Quality and Regulatory Lead in Hong Kong.
• You will be based in Hong Kong, 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.

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

• Bachelor’s degree in quality engineering,Electrical Engineering or Mechanical or equivalent
• Minimum 10 years working experience in product development projects of electronics in medical device (consumer products as plus)
• Applied knowledge of appropriate global consumer product regulations, requirements, and standards such as IEC 60601, IEC60335, ISO 9001 and ISO13485.
• Strong experience in Risk Management (IEC 14971)
• 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.
• Communicate globally, across teams and programs, from senior executives to administrative support personnel and external parties.
• Abletothrive in a fast-paced, team-oriented, new product development environment.
• Business travel in South China region up to 30%

• Learn more about .
• Discover .
• Learn more about .