Quality Technician

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Performs activities related to the support of all established quality system, product release cGMP
compliance requirements in the assigned area of the facility.
Conduct process monitoring and support adherence to quality standards of products, processes and areas.
Shift Quality Technician on a front line manufacturing team delivering on customer focused quality decisions in real time.
Ensure effective and efficient handover to rotating shift team members.
Ensure adherence to quality plans and conduct final review of batch documentation, including release of product on the MIS system.
Monitoring of area housekeeping programmes, to ensure standards are maintained and records are completed and compliant.
Develop, implement and monitor visual standards to meet agreed Customers specifications.
Drive adherence to quality standards and the application of risk-based decisions, using tools such as PFMEA and risk assessment.
Generate and review of temporary deviations, process and rework instructions.
Trouble-shoot quality issues within manufacturing.
Apply systematic problem-solving methodologies such as DMAIC and Process mapping.
Utilise appropriate statistical tools such as SPC in identifying, prioritising and resolving issues.
Monitor and analyse data to ensure adherence to standards and identify opportunities to improve processes and procedures to deliver on waste elimination and maintain quality.
Direct involvement in New Product Introductions, Continuous improvement projects and initiatives.
Maintain Visual Management boards, quality metrics, reporting systems and prepare required reports.
Conduct internal quality audits to ISO and GMP requirements and provide support for Supplier, Customer and Regulatory audits.
Develop and provide training where required, including GMP training programmes
Quality support on cross-functional teams working on process change review and related assessment prior to implementation of change.
Completion of assigned actions in relation to Customer complaints, Risk assessment, NC containment, investigation and CAPA implementation.
Support Validation activities ensuring compliance to all relevant Quality Standards and Regulatory requirements.
Project work as assigned.
Drive full compliance to GDP & GMP requirements.
Ensure Quality and EHS policies and procedures are adhered to at all times.
Where applicable Compile and review and signoff of sterile product batch records for routine commercial sterile product loads, Including all prescribed testing.
eg residual data, Bioburden, LAL and cycle conditions.
Where applicable supports selection of Product for testing and ensure that the associated documentation is completed to the required standard
Education / Experience Requirements
Diploma in Quality/Engineering / Science or equivalent qualification.
Min 4 year industry experience in a medical device manufacturing environment or similar.
Knowledge of quality principles and ability to utilise these in a manufacturing environment.
Excellent attention to detail and GDP.
Experience within a hands on line support type role is highly desirable.
Good understanding of problem solving and statistical methodologies is required.
Yellow belt level desirable.
Excellent Computer Skills (Word, Excel and PowerPoint).
Excellent communication (both verbal and written) & interpersonal skills.
Specialized Skills / Other Requirements
Customers and Vendors
Ability to understand customer relationships
Ability to generate appropriate relationships with customers
Ability to deal with difficult customers communications
People
Clear verbal and written communication.
Ability to work in a cross functional team.
Ability to use interpersonal skills to deal successfully with day to day people related issues
Demonstrates behaviours in line with Teleflex Core Values.
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