Design QA Engineer II

• Job Responsibility 岗位职责:

• Responsible for quality assurance of design control, monitor of design control, coordinate and track of design defect, and Drive quality improvement project from design control.
• Ensure design control process compliance throughout whole product lifecycle.
• Review and Approve DHF.
• Establish, maintain, continual improve QMS and ensure fully meet regulation requirement.
• Monitor QMS process performance with data analysis.
• Lead quality improvement project from system level.
• Offer quality training.
• Any agreed-to works by superiors.

• Qualification任职资格:

  Functional Knowledge 职能知识：

• Requires expanded conceptual knowledge in own discipline and broadens capabilities
• Be familiar with ISO 13485, GMP and relative quality management system regarding IVD/MD product design control.  

• Business Expertise业务专业知识:

• Understands key business drivers; uses this understanding to accomplish own work

• Leadership领导力:

• No supervisory responsibilities but provides informal guidance to new team members

• Problem Solving解决问题:

• Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents

• Impact影响:

• Impacts quality of own work and the work of others on the team; works within guidelines and policies

• Interpersonal Skills人际交往技巧:

• Explains complex information to others in straightforward situations

• Education & Experience学历与经验:

• Bachelor’s degree in field with 2+ years exp. OR
• Master’s degree in field with 0-2 years exp.
• At least 5 years of work experience related to software or software quality management, experience in quality assurance supporting new projects or design changes.
•  Fluent in spoken English.

• If you also have the following experience, it will be a plus:

• Familiar with ISO 13485, GMP, and quality management systems related to in vitro diagnostics/medical device product design control.
• CAPA (Corrective and Preventive Actions), risk management processes. System-level core team quality assurance support, including hardware, software, reagents, and their combinations. FDA audit preparation and experience with FDA audits.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.