• 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
• 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
• Design and validate Quality System processes where appropriate (CSV and
• 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
• 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.
• Process Excellence Green Belt/Black Belt
• Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.