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
- 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.
- 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.
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