Quality Engineer

Quality Engineer Alton 7.30am – 4.00pm Monday – Thursday 7.30am – 2.00pm Friday 37.5 Hours About the role: Reporting to the Quality Assurance Supervisor, the main purpose of this post is to ensure that any customer quality issues and consumer complaints are investigated and responded to in a timely manner. To support with investigations into non-conformities whilst ensuring that any corrective/preventative actions are effective and meet regulatory expectations, and to assist in the support of new product introduction. The post holder will have a good knowledge of quality improvement tools and techniques and be an experienced auditor. This is a hands-on role which will involve spending time on the production lines and some product inspection. Key Duties and Responsibilities: Following training, the key duties of the post are as follows * Co-ordinate the QMS internal audit programme including planning the audits, assigning the auditors, carrying out audits, ensuring audit reports are produced and signed off in a timely manner, ensuring corrective actions are logged. * Support the operations team in carrying out investigations into internal non-conformities or quality issues -advise problem solving techniques that could be used to establish the root cause of the issue and identify appropriate corrective and/or preventative actions where applicable and in a timely manner. * Manage the Change Control Process * Investigate customer quality issues and consumer complaints and ensure that responses are provided in a timely manner. * Review and complete Deviations in a timely manner- allocate actions to the QC department as applicable * Attend customer meetings as required * Monitor the corrective and preventative action (CAPA) process by ensuring proposed actions are relevant and applicable and by carrying out verifications on these actions. * Carry out effectiveness checks on CAPAs. * Assist in the review and update of Risk Assessments as required * Support the new product introduction process by providing specific quality engineering expertise to NPI projects * Participate in line trials. Present findings at post line trial run review meetings * Assist and support the Administration Team with completion of PQR reports * Carry out any other reasonable projects and duties as determined by the Quality Assurance Supervisor or Quality Manager Formal Qualifications and Experience required: * Qualified and experienced internal auditor * Previous experience in a similar quality role * Good knowledge of quality analytical/problem solving tools and techniques gained through practical experience * Ability to handle multiple demands, to be self-managing and to work under pressure * Ability to gain respect and credibility within the team, through demonstration of technical knowledge and transferable skills * Ability to manage a team, provide support and develop team members in line with Company values. * Educated to degree level or equivalent in a science, engineering or manufacturing related discipline * Experience of working within a GMP environment Person Specification: * A confident people person able to influence and communicate effectively with all levels of the company * Strong verbal communication and interpersonal skills. Ability to listen, discuss and advise * A team player * Ability to make own decisions * Ability to handle multiple demands and changes in priority and workload * Ability to gain respect and credibility through demonstration of technical knowledge and transferable skills * Advanced level of literacy and numeracy required * Ability to use computerised information systems to input, retrieve and update all relevant data – Candidates should be able to demonstrate that they are comfortable with computer systems. It is not considered relevant where that experience has been gained. * Good knowledge of Microsoft Office package – Word, Excel, Outlook and PowerPoint – A moderate understanding is essential