Sr. Design Assurance Quality Engineer

Summary:

The Design Quality Assurance team is an integral part of developing and bringing to market innovative new products and technologies that make life more rewarding and dignified for people with challenging medical conditions.

Responsibilities:

• Associates within the Design Assurance team
• Complete Performance Management and Development Plans with team members
• Resource planning, allocation, and monitoring on projects and initiatives
• Mentor Design Assurance team on projects and ensure completion per timelines and  expectations 
• Lead on Design Assurance issues raised by team members and escalate for resolution if required
• Be a core team member on SPRING or Continence Care projects as required
• Drive continuous improvement initiatives within the Design Assurance function
• Support the internal and external audit program 
• Complete assigned Impact Assessments within the change control system
• Support periodic review of assigned design control procedures
• Support the development of the strategic direction for the Design Assurance function
• Manage training plans for the team   
• Complete gap assessments to new standards as required
• Ad hoc travel

Essential Functions of the Role**:

• The successful candidate will lead a Global Team of Design Quality Assurance Engineers and will engage with cross functional partners as part of driving the new product development process.

Work Experience Requirements

•   8+ years of overall experience is required
•   Relevant experience in the medical device industry or equivalent regulated industry
   

Education Requirements

•   Degree in Engineering/Science Discipline or Quality Engineering Qualification 

Specialized Skills/Technical Knowledge:

• Experience in Quality Systems and Design Assurance
• Working knowledge of ISO 13485 and FDA 21 CFR Regulations and BS EN ISO 14971
• Software: Knowledge and experience of Word, Excel, PowerPoint and Minitab  
• Knowledge of statistical data analysis
• An ability to work independently and as part of a team. The successful candidate will be able to organise their own work on a routine basis and requires minimal supervision
• Experience in working in cross-functional teams

Local Specifications (English and Local Language):

• Fluency in English is required