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Vacancy Details


106941 - Senior Quality Engineer - Galway

Contract Type: Contract
Location: Galway
Date: 12/02/2020
Job Reference: 106941
Contact Name: Orla Crowley
Contact Email:

Job Description

Senior Quality Engineer - Galway - 106941
Senior Quality Engineer
Our client, a leading global medical device MNC requires a Quality Engineer for one of their sites in Galway.
Title: Design Assurance SME Post Market Sustaining Engineer
Duration: 12 months

Job Summary
  • Support sustaining commercial projects from a Design Assurance perspective.
  • You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.
  • Support teams to implement EUMDR requirements
  • Guide & complete software validations for excel & business objects.
  • Support the introduction/implementation of product/process/materials changes to the manufacturing operation.
  • You will assess the patient risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
  • Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
  • Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
  • As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
  • You will generate and approve change requests.
  • Lead incident investigation analysis (IIA) and timely completion of same.
  • At the appropriate point during post commercialization, work to ensure a smooth transition of product
  • Quality responsibilities from DAE to the Post Market Product Assurance group (reliability/performance metrics reporting, etc.).
  • Deliver constructive feedback and provide quality leadership in a cross-functional environment
  • Prioritise timely completion of complaint investigations, CAPA decisions, and DHR reviews, ensuring that corrective action decisions and investigations are based on sound engineering analysis and review.
  • Initiate discussions with management, Field Assurance, and QA via the product quality meetings when new failure mode trends are identified, providing field performance data as it becomes available.
  • Develop and maintain a robust process for identifying and monitoring root cause failure mode''s, frequency, and severity.
  • Provide statistical data to Field Assurance, QA and management on product performance, effectively describing clinical observations and the relationship with device performance
  • Represent QA in product Risk Analysis updates for assigned products.
  • Maintain, monitor and report trend analysis information on assigned products.
  • Collaborate with PXM to ensure that field returns are evaluated appropriately to deliver clear results and potential root causes are identified.
  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialise in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
The Ideal Candidate
  • We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science)
  • Desirably with a minimum of 5 years’ relevant experience with a specific skill set (EUMDR & Excel validations).
  • You are a dynamic team player, can work effectively and proactively on cross-functional teams.
  • Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
  • You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Quality Engineer role in Galway please contact Orla Crowley on 086 0449473 /

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