Description
This well established medical device manufacturer in Devon is now urgently seeking a Quality engineer to support the production teams for introducing new products, defect reduction and improving process.General responsibilities include;
- Ensure non-conformances are reported when they occur.
- Coordination and reporting of relevant failure investigations and subsequent corrective and preventive actions and reviewing effectiveness of these.
- Evaluate, trend and report internal non-conformances to establish priorities and identify common threads aimed at a continuous reduction in internal non-conformance occurrences via internal or supplier process improvements.
- Collect, analyse, trend and report data on rejects from routine production inspection and QC tests and related processes to establish improvement priorities and identify common threads aimed at a reduction in external complaints. Work with QA Specialists and others as appropriate to ensure that production inspections and QC tests are aligned with customer needs.
- Ensure required processes, practices and standards in production, quality control and related areas are validated, and continuously improved working with unit managers, manufacturing engineers and team leaders to achieve this.
- Preparation of miscellaneous documentation/reports.
- Support product development/transfer activities.
- Conduct QMS, manufacturing and supplier audits.
- Provide support to Quality Assurance Manager during external audits
Essential Requirements;
- Recognised Engineering Apprenticeship with the relevant qualifications (HNC/HND/Degree) or a recognised Engineering Degree and subsequent experience.
- Ideally having a recognised Institute Membership/Incorporated Engineer.
- Formal training and qualification in Six Sigma techniques would be an advantage.
- Experience of working within an ISO 9001/ISO 13485/TS16949/Pharma regulated manufacturing environment in a Quality Engineering role.
- Knowledge of systems adopted within a regulated Manufacturing facility.
- Background in mechanical/manufacturing engineering, inspection techniques, knowledge of Quality Assurance and Quality Control Systems.
- Knowledge of quality tools and techniques, e.g. Discipline investigations, 5 Why, 7 Step, Ishikawa diagrams, SPC, FMEA, Pareto analysis, parts and process capability studies.
- Able to investigate and solve complex issues and define root cause using good analytical skills.
- Knowledge of and ability to use Microsoft Office applications including Access, Excel, PowerPoint, Visio, Project and Word. Knowledge of Quality Analyst or MiniTab.
- Ability to work in a team oriented way towards problem resolution and continuous improvement.
- Able to read and interpret engineering drawings.
- Able to work in a cleanroom environment.
My client is looking to pay up to £40,000 for the right candidate, so if you believe you have the correct experience then please send me your CV and I will be in touch shortly as they are looking to interview ASAP. Sthree UK is acting as an Employment Agency in relation to this vacancy.