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Supervisor Design Assurance

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Date: Jun 1, 2022

Location: Ballina, MO, IE

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Ballina 
Department: Quality 

The primary purpose of the Design Assurance Supervisor is to lead members of the Design Assurance team and support DA initiatives as required to maintain and continuously improve the DA function. 

•    Supervise Associates within the Design Assurance team
•    Resource planning, allocation, and monitoring on projects and initiatives
•    Mentor DA team on projects and ensure completion per timelines & expectations 
•    Lead on DA issues raised by team members and escalate for resolution if required

•    Drive Continuous improvement initiatives within the DA function

•    Represent Design Assurance on project teams as required
•    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 DA function
•    Manage training plans for the team   
•    Complete Gap Assessments to new standards as required

Essential Functions of the Role**:
•    Walking
•    Lifting
•    Sitting


Work Experience Requirements
•    Number of Overall Years Necessary: 5-8
•    Relevant experience in the medical device industry or equivalent regulated industry


Education Requirements
Degree in Engineering/Science Discipline and Quality Engineering Qualification or equivalent 
Certified Quality Engineer qualification or equivalent

Specialized Skills/Technical Knowledge:
Knowledge of statistical data analysis, ISO 13485 and FDA 21 CFR Regulations, BS EN ISO 14971
Software: Knowledge and experience of Word, Excel, PowerPoint and Minitab  

Local Specifications (English and Local Language): English

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

Job Req ID: 30312