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EXPERIENCED ADVANCED QUALITY ENGINEER REQUIRED FOR LEADING MEDICAL DEVICE COMPANY

Responsibilities:

• During the development and introduction of new products and technologies, lead the implementation of quality systems and work closely with Design, Quality and Manufacturing Engineering personnel on product and process design.
• Technically understanding the process, provide quality engineering validation support. Develop and provide input to validation protocols, coordinate inspections and analyze the results. Ensure agreement on inspection techniques, equipment and acceptance criteria.
• Design and implement new inspection technology, metrology equipment, functional gauges and fixtures to facilitate development, incoming and in-process inspection and testing.
• 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. Lead risk and failure analysis (FMECA/PFMEA) and interpret test results to predict product reliability.
• 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.
• Coordinate and ensure timely completion of the project activities involving inspection support for product and validation requirements.
• 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 and problem solving 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.
• 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 technical specifications, process validation, problem solving, development of sampling plans, inspection techniques and audits findings.
• 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.

Requirements:

Bachelor Engineering Degree (Mechanical, Manufacturing or Electrical Engineering or Materials Science).

Equivalent qualifications in other academic disciplines will also be considered with respect to related experience.

Applicants should also have 3-5 years related manufacturing and/or Quality Engineering experience in an R&D or manufacturing environment.

Contact Timmy Hayes@SIGMAR RECRUITMENT, (021) 4315770

Or send CV in strictest confidence to thayes@sigmar.ie