Supervisor Design Assurance

We Make Life More Rewarding and Dignified 

Location: Ballina 
Department:  

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.

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.

Responsibilities:

•    Supervise 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

Requirements:

•    8+ years of overall experience is required

•    Degree in Engineering/Science Discipline or Quality Engineering Qualification 

•    Relevant experience in the medical device industry or equivalent regulated industry
•    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

 Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc. (JDS Inc.), a 100-year-old company. Hollister is guided by the shared Mission of JDS Inc., to make life more rewarding and dignified for those who use our products and services. www.Hollister.com 

Hollister is an EO employer – M/F/Veteran/Disability

Job Req ID: 31777