Senior Quality Engineer

4 days ago

Galway, Ireland Cregg Full time

Exciting opportunity for a Senior Quality Engineer to join Galway's leading multinational medical device manufacturer.
Job Description:
Support sustaining commercial projects from a Design Assurance perspective.
You will be directly involved in making sure products are maintained through the full product lifecycle and that these products comply with global standards.
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.
Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.
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 investigation analysis and timely completion of same.
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 specialize 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.
Collaborate with complaints team for complex investigations.
Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
Key Skills & Experience
Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
5-8 years' experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
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