Job Description

In this role, you have the opportunity to be

• A Product Quality Engineer within our Hospital Patient Monitoring(HPM) team. The QA/QE engineer is responsible for driving quality to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. Participates in the change management process to assure the products or services continue to meet customer requirements. Uses data sources to identify opportunities to improve quality. Participates in cross-functional teams with other business and engineering disciplines. Provides independent oversight and review of the project deliverables throughout the product lifecycle.

You are responsible for

• Ensure that design meets compliance standards, reliability and quality management system requirements

• Ensure design processes compliance to PQMS procedures/work instructions, including local process/procedure development as appropriate.

• Responsible for quality planning of local design control management system e, transfer and maintenance.

• Design review as a core team member and / or independent reviewer)

• Take part in risk assessment activities as a cross-functional team member including product risk, FMEA and PFMEA.

• Responsible for Verification & Validation activities (planning, execution and deliverable) review and approval for confirming design outputs comply with requirements of design inputs and traceability

• Be responsible for change request review, including judgement for final disposition of defect tracking

• Responsible for DHF Review

• Ensure the of deliverable Design transfer sufficiency and effectiveness

• Responsible for Design and/or Device Master Record change review & approval

• Product quality improvement and assist in problem solving

• Support Post market risk analysis

• Accountable for performing timely quality engineering and quality assurance tasks provides assistance ensuring Manufacturing quality systems are maintained and Documented.

• Participate and supports the completion of NPI and Product transfers in the factory.

• Report on product timelines and tracking of products transfers

• Performs validation protocols and coordination of production builds to support validation activities

• Analyze data for reports and validation activity as well as process improvement initiatives.

• Involve Leading other process Quality engineers

• Leads single or complex validation and process improvement activities at one time

You are a part of

•Professional PQE Team, with multiple team peers globally.

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

• Education: Bachelor degree, major in science or engineering discipline is preferred.

• Experience: More than 3 years’ experience in quality engineering or quality management in medical device industry. More than 2 years’ experience in design and development quality management for Class II & III active medical device

• Fluent in English and Chinese Languages is required.

• Competencies and Skills:

• Sufficiently understand medical device regulatory and standards, especially for MDD 93/42/EEC or EU-MDR, QSR part 820, China GMP and ISO 13485.

• Appropriate awareness of medical device industrial standard, such as IEC60601, GB9706 and ISO 14971

• Be familiar with product design and development process & critical phase, prefer for IDP or CMMI etc.

• Be familiar with typical control measures and methodology for design quality and product quality, prefer for DFSS or GB.

• Prefer for knowledge of project management.

• Strong logical thinking

Prefer for the product knowledge of defibrillator or patient monitor