Sr. Design Assurance Quality Engineer II

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
• Resource planning, allocation, and monitoring on projects and initiatives
• Mentor Design Assurance team on projects and ensure completion per timelines and expectations
• Support Design Assurance issues and escalate for resolution if required
• Be a core team member on SPRING or Continence 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
• Complete gap assessments to new standards as required
• Ad hoc travel

Essential Functions of the Role**:

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

Work Experience Requirements

• 5 to 8 years of design assurance medical device experience is required.
• Relevant experience in the medical device 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 organize their own work on a routine basis.
• Experience in working in cross-functional teams