Design Quality Engineer

Pe Global

Cork

Responsibilities: Develop effective Process Verification Strategies working with all product development cycle stakeholders.Work with the suppliers to produce quality process specifications as required during the development and implementation of new products. Approve design specifications (e.g. drawings, protocols) as defined for own scope of responsibility.Lead/support the implementation of new inspection technologies that achieve process reliability and productivity improvements with a focus on in-process inspection and Non-Destructive Testing (NDT)Establish a system of metrics to continually monitor measurable quality performance. Select, setup and establish calibration procedures for gages and equipment used in the Additive Manufacturing Process.Compile and execute validation protocols for new product/processes. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production. Provide statistical support for DOE (Design of Experiments), sampling plans, capability assessments, rationale development & hypothesis tests as required.Document and maintain in good order all relevant Quality documents. Deliver compliant transfers of Design History Files where required, ensuring transferred systems are understood and integrated into the Quality System. Supporting risk assessment activities: Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques to minimise potential risk during development/implementation activity. Ensure effective problem analysis/complaint investigation (CAPA) as required and define through negotiation effective corrective actions. Working with relevant business stakeholders, support and lead in the Non-Conformance (NC), Corrective and Preventative Action (CAPA) investigations and general problem solving for both design and processLiaise with R&D to ensure CTQ (Critical To Quality) specifications are agreed and documented for all NPD. Support Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor.Support QA input in Design for Manufacture activities.Ensure consistency with other team QE’s, site Quality Systems and corporate Quality Systems. Ensure compliance with all Documented Quality system, as per FDA QSR’s and ISO 13485/9001 requirements etc. during day to day activities. Travel up to 40% will be required. Education and Experience: A 3rd degree level qualification in mechanical/industrial engineering or related field essential. At least 4 years or more years related experience in a similar role for a fast paced organisation. Knowledge and appreciation of manufacturing processes and controls. Knowledge and understanding of process validation techniques such as risk assessment, validation planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), change control and process verification. Must have a good understanding of Geometric Dimensioning and Tolerancing and be fully conversant with engineering drawings. An advanced degree with Six Sigma, or ASQ Certification. Specialized Q&C Competencies: Quality Statistics, Data Analysis and Tools. Technical Transfer & Scale Up. Interested candidates should submit an updated CV. Please click the link below to apply, call Sean on 0214297900 or alternatively send an up to date CVsean.molloy@peglobal.net. This job originally appeared on RecruitIreland.com.

2221 days ago