Quality Assurance Technician

Quality Assurance TechnicianLocation: Biopure - Havant Benefits: Enhanced Carer/Paternity Leave, Additional Holiday, EAP and moreWebsite: https://en/Group: https://

This role will focus on:

As Quality Assurance Technician you will be responsible for managing the company ISO9001 Quality Management System (QMS) and the documentation required to ensure the quality of products and components throughout the production process.

Key Responsibilities Include:

• Raising non-conformance's for internal issues, and on receipt of complaints from customer, and communicating to relevant teams for investigation. You will also be responsible for communicating any response / queries to the customer or internally as required, providing regular updates to the QA Manager. Once complete, you will support the review of CAPA after the required period.
• Maintain and update the calibration system in conjunction with supply chain, liaising with production team, reference repairs as required.
• Maintain quality performance data and communicate it to senior management as required.
• Provide coaching for staff regarding quality management system requirements.
• Create, update, and maintain QMS documentation.
• Contribute to quality improvement activities.
• Deputise for the QA Manager regarding QMS requirements.
• Generate change controls from internal and external communications.
• Support the QA Manager during ISO 9001 certification audits.
• You will undertake internal audits and liaise with external sources to ensure completion.
• You will maintain all relevant documentation to ensure you are complying with the BS EN ISO 14644 clean room requirements, BS EN ISO 9001 and some GMP standards.
• Ensure compliance with all company health and safety rules and regulations at all times, including contributing to any company health and safety initiatives and activities.
• Liaise and collaborate with the ISO 14001 Environmental Standards Team.

To be successful in this role, you will need:

• You will have significant experience of maintaining Quality Management systems / BS EN ISO 9001
• You will have experience of ERP/eQMS systems (If you have Microsoft AX and eQMS system TrackWise even better)
• Proficient in MS Office
• Experience / training in Internal Audit completion.
• Have an understanding of lean manufacturing including MUDA, 6S and Kaizen.
• Demonstrate an understanding of cause-and-effect methodology, root cause analysis and the DMAIC process.

As a growing and ambitious organisation with a presence in over 60 global locations and across multiple markets, we can offer you the working environment and support needed to be successful. We are committed to achieving workforce diversity and creating an inclusive working environment. We welcome all applications irrespective of social and cultural background, age, gender, disability, sexual orientation, or religious belief.