Quality Technician

Position Summary

Title:                             Quality Technician (Development Value Stream)

Reports to:                   Quality Engineer

Department:                Quality

Purpose of the role:    

This role is to provide QA support and decision making to the Development Value Stream, through the entire product development process up to and including transfer to production.

Principal Responsibilities

Key responsibilities will include (but are not limited to) the following:

Shift Quality Technician providing front line manufacturing support for multiple development projects. Ensure effective and efficient handover to rotating shift team members as required.

Generate and ensure adherence to quality inspection plans and conduct final review of batch documentation, including release of product on the MIS system.

Coordinate, support and/or perform the inspection of development product including but not limited to FAI, checklist builds, builds under deviation/Instruction and protocol requirements, to support project progression and product release.

Review & approval of documentation for early development (route 1 & 2) builds ensuring all build checklist requirements and agreed inspections per quote are completed prior to release of product.

Coordinate Product Complaint(PC) and Non-Conformance (NC) processes and drive timely completion of phases.

Trouble-shoot quality issues within cross-functional project teams. Apply systematic problem-solving methodologies such as DMAIC and Process mapping.

Drive adherence to quality standards and the application of risk-based decisions, using tools such as PFMEA and risk assessment.

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

Specialized Skills / Other Requirements

Key Responsibilities continued 

Maintain Visual Management boards, quality metrics, reporting systems and prepare required reports, highlighting trends and issues to QE as appropriate

Conduct internal quality audits to ISO and GMP requirements and provide support for Supplier, Customer and Regulatory audits.

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.

Support to Development Value Stream on item set up and approval processes.

Updating Project Folders with Quality documents as required to ensure compliance with QMS.

Project work as assigned.

Drive full compliance to GDP & GMP requirements.

Ensure Quality and EHS policies and procedures are always adhered to.