Overview

• Actively support all Compliance Initiatives with the Value Stream and Plant 
• Actively support all defined Value Stream and Plant goals and objectives. 
• Work as an integral member of authorised Value Stream Process Excellence 
initiatives 
• Identify projects to resolve scrap, reprocessing and special causes that have a 
negative impact on Value Stream and Plant Goals and Objectives. 
• Compile Quality Process Specifications for new/transferred products/processes 
• Validate new/changed production processes/systems with Business Unit 
personnel 
• Design and validate Quality System processes where appropriate (CSV and 
Inspection Process) 
• Reviews product designs, test protocols and co-develop critical 
characteristics/tolerances for initial testing and validations and subsequent 
routine manufacturing controls. 
• Conduct internal Quality System Audits as necessary 
• Participates in design evaluations where appropriate 
• Participates in process evaluations (e.g. FMEAs). 
• Devises and implements methods and procedure for inspecting, testing and 
evaluating plans for subsequent routine production. 
• Support Quality System activities within manufacturing cells such as Internal 
Audits, complaint investigations, close call and corrective action investigations. 
• Perform/document dimensional/visual inspections and non conformance and 
deviations as required 
• Manage a variable workload to meet operational requirements. 
• Ensure that all Health, Safety and Environmental requirements are fulfilled. 

QUALIFICATIONS & EXPERIENCE 

ESSENTIAL: 
• Engineering degree Quality / Manufacturing / Engineering and/or 
• Minimum 2 – 3 years experience in Quality Assurance/Engineering 
• Proven track record in Compliance & Continuous improvement projects 
• Basic PC Skills. 
• Ability to interpret engineering drawings/specifications. 
• Familiarity in areas of various Inspection Techniques. 
DESIRABLE: 
• Process Excellence Green Belt/Black Belt 
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment. 

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