Site Quality Engineer

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.

Main Responsibilities:

• 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.

• 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.