- Reference: CJ43784
- Job Type: Permanent
- Location: Cork, Munster
- Category: Engineering, Technical & Manufacturing
Title: Advanced Quality Engineer
Leads the development and introduction of quality systems to support the Research, Development and Introduction of new Products, Processes and Technologies.
Has responsibility for quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer whilst ensuring compliance to FDA Quality System Regulations and ISO 13485.
• Lead the implementation of quality systems and work closely with Design, Quality and Manufacturing Engineering personnel on product and process design during the development and introduction of new products and technologies.
• Ensure that customer requirements are incorporated into product functional specifications and lead risk and failure analysis (FMECA/PFMEA) to ensure functional specification requirements are fully met during design validation.
• Working from the design input requirements, functional specifications and risk analysis, develop necessary confidence levels and derive the resulting product and process validation and test plan. Interpret test results to predict product reliability.
• Provide process validation support both internally and with vendors. Technically understand the process in question, develop and provide input to process validation protocols, coordinate inspections and analyze the results. Ensure agreement on inspection techniques, equipment and acceptance criteria. Work with the Project Team to achieve a robust validated process
• Lead the development of incoming attribute charts, in-process inspection procedures and final inspection plans. Minimise inspection costs while maintaining integrity and reliability of the product.
• Design and implement new inspection technology, metrology equipment, functional gauges and fixtures to facilitate development, incoming and in-process inspection.
• Will apply world class techniques (Six Sigma, Anova, Taguchi, SPC, Gauge R&R etc.) to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
• Has the authority to order the cessation of all activities in relation to design and process validation and new product introduction. Also has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed.
• Will develop supplier quality systems related to new product development and ensure their ability to deliver new products and components right first time. Will assist vendors in the resolving quality issues in relation to:
• Audit findings
- Technical specifications
• Process validation
• Problem solving
- Development of sampling plans
- Inspection techniques
• Coordinate the day-to-day inspection support for validation requirements and ensure completion of inspection requirements to ensure timely completion of project timelines.
• Ensure the efficient and timely transfer of Quality systems knowledge to unit quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment. Ensure all appropriate documentation is in place prior to production start.
• Lead the resolution, analysis, problem solving and resolution of new product related customer complaints.
• Act as statistics expert for capability studies. Teach statistical analysis and design of experiments techniques internally and externally across all functions.
• Bachelor Engineering Degree (Mechanical Engineering, Manufacturing Engineering, Electrical Engineering or Materials Science or equivalent).
• Good computer skills (word processing, spreadsheets, data base).
• Working knowledge of CAD/CAM/CAE computer systems is desirable.
• 3-5 Years related Quality Engineering experience in an R&D or manufacturing environment.
• Excellent analytical skills and promotes a problem solving work style.
• Excellent interpersonal communications skills.
• Demonstrated ability to operate small hand tool, inspection equipment.
• Demonstrated mechanical and/or electrical problem solving skills.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email email@example.com
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