An exciting opportunity has arisen, supporting a large healthcare organisation as a Site Quality Engineer.
The post will be based in the Midlands area on a fixed term contract basis for 6 months.
The post holder will be an advocate for the organisation’s quality system and demand the highest standards from their suppliers.
- Act as an immediate assistant to the Operational Quality Manager;
- Maintain compliance of PCR test kits to ISO13485;
- Plan, implement, and guarantee that the procedures meet operational quality requirements of the end-to-end kitting process and coordinate with central quality group;
- Obtain resolution on areas identified as non-conformant;
- Document all processes and procedures and report the effectiveness of the Quality Management System (QMS);
- Promote awareness of regulatory and QMS requirements throughout the organisation;
- Oversee new kit introduction and approvals, and validation of new processes;
- Provide quality advice and support to other departments;
- Monitor trends in product quality and take corrective action when required;
- Maintain good technical knowledge of products and work cross-functionally to improve processes and procedures;
- Drive root-cause analysis and implement corrective and/or mitigating actions to resolve problems;
- Work with various stakeholders in the manufacturing process;
- Build relationships with stakeholders and communicate with them effectively and clearly;
- Support the long-term relationship between external partners and colleagues, aligning to a common goal and approach;
- Assess components for conformance to specification;
- Identify and report any non-conformances to central quality;
- Assist in ensuring adherence to quality metrics;
- Ensure end to end kitting is operated to all approved work instructions and required documentation is completed in full;
- Gather data concerning product conformity;
- Support commercial partners across multiple sites providing increased kitting capability and contribute to the supply and delivery network.
A successful candidate will have:
- Experience of supply chain and logistics;
- A working knowledge of ISO13485;
- Experience in operating within a quality system environment;
- A high level of Excel skills and excellent attention to detail;
- The ability to be adaptable to a complex and changing environment, and prioritise accordingly;
- Excellent analytical, time management, and problem-solving skills;
- The ability to build strong relationships and work closely with several different stakeholders and teams in various capacities;
- Proven experience of data-driven decision making and managing documentation and databases.
For further information on this role please contact Donna Larder on 0161 241 9674 and send a copy of your CV to firstname.lastname@example.org