Description:
This role is to provide QA support, product release and decision making to the Manufacturing Operation, conduct process monitoring and support adherence to standards and drive continuous improvement initiatives and day to day problem solving.
Principal Responsibilities
Key responsibilities will include (but are not limited to) the following:
- 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.
- Product Release: Conduct final review of batch documentation, including release of product on the MIS system. Ensure adherence to quality inspection plans.
- Develop, implement, and monitor visual standards to meet agreed Customers specifications.
- Generate and review of temporary deviations, process, and rework instructions.
- Coordinate Product Complaint (PC) and Non-Conformance (NC) processes and drive timely completion of phases.
- Trouble-shoot quality issues within manufacturing. Apply systematic problem-solving methodologies such as 3C, DMAIC and Process mapping. Utilise appropriate statistical tools in identifying, prioritising, and resolving issues.
- Drive adherence to quality standards and the application of risk-based decisions, using tools such as PFMEA and risk assessment.
- Maintain Visual Management boards, quality metrics, reporting systems and prepare required reports, highlighting trends and issues to QE as appropriate.
Principal Responsibilities Continued
- 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.
- Develop and deliver training where required across multiple shifts.
- 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 where relevant by ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- Direct involvement in New Product Introductions, Continuous improvement projects and initiatives
- Conduct internal quality audits to ISO and GMP requirements and provide support for Supplier, Customer and Regulatory audits.
- Project work as assigned.
- Drive full compliance to GDP & GMP requirements.
Education / Experience Requirements
- Diploma in Quality/Engineering / Science or equivalent qualification.
- General understanding of the requirements of a regulated medical device industry.
- Knowledge of quality principles and ability to utilise these in a manufacturing environment.
- Good understanding of structured problem-solving.
- Excellent Computer Skills (Word, Excel, and PowerPoint)
- 2+ year industry experience in a medical device manufacturing environment or similar is desirable.
- Experience within a hands-on line support type role is desirable.
- Understanding of Lean Principles, certified to yellow belt level is desirable.