• Supporting operations providing directed quality engineering support. • Ensuring appropriate risk management documentation such as risk analysis, pFMEA and dFMEA are up-to-date and appropriate at all times. • Reviewing and approving quality related documentation particularly relating to upkeep of manufacturing documentation and Device Master Record of production area. • Supporting operations, manufacturing operations and key vendors in yield improvement activity. • Assisting in the development of process optimisation, applying measurement system analysis and formal process validation techniques. • Leading, facilitating and participating in formal problems solving to overcome production issues. • Compiling and reporting Quality Measurement Indices as required. • Engineering Executive role in handling Non Conformance relating to production concerns. • Perform corrective and preventive action (CAPA) activities.
The ideal candidate will have:
• HND or equivalent calibre in engineering, science or technology discipline. • Preferably minimum of two years in a quality-related field. • Demonstrable risk-based approach. • Preferably exposure to common electronics manufacturing issues. • Preferably experience of a Medical Device manufacturing environment or equivalent (e.g. pharmaceutical or possibly high specification consumer electronics). • Proven problems solving ability (e.g. 8D, KT etc.).
This company is a leading expert in immunoassay development and manufacturing services, and provides an extensive portfolio of products and technologies to the global diagnostic and pharmaceutical markets.
The Senior QA Associate ensures that all QA activities comply with ISO9001, and the site quality management system.
A background in Quality Assurance with good working knowledge of ISO9001 and ISO 13485 or a related discipline is necessary for this role, along with the ability to develop strong relationships with external and internal customers from diverse backgrounds.
You must have the capacity to bring logical thought processes and impartiality to solve practical problems and the ability to work unsupervised and under pressure in a busy fast paced environment.
- Review of batch records. - Identifying and helping to implement improvement opportunities within the QA department - Advising and supporting other departments in QA related issues - Representing QA in inter-departmental / customer meetings as required - Coordination of change control activities - Completion of quality and product-related customer questionnaires - Review of qualification / validation documentation - Maintenance and review non-conformance / deviation database - Maintenance and review customer complaints file - Performing general activities required for the maintenance of the Quality Management System - To work in accordance with site and legislative employment policies and safety requirements.
They deliver exceptional products and technologies that people rely on to enjoy a better quality of life. They embody the phrase "work hard, play hard" and look for their people to be active participants in life, to make work fun as well as challenging.
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