Job Title: Quality Engineer II (Design Assurance) Location: Galway-Permanent Industry: Medical Device Company information: Galways world leading medical device manufacturer Role Profile Working under the Principal Engineer this role is ideal for candidates from a strong R&D or MDR background who want to focus on Design Assurance.
This role will be 20% customer complaints with the remaining time focused on Design Assurance.
Reach out to Rachel to discuss.
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Qualifications / Professional Skills / Knowledge Degree required: Level 8 Degree in a STEM discipline Minimumof2-3 years experience in a Design Assurance/Quality/R&D/Production capacity.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Key skills or qualifications: Supports the approval of FDA pre-sub, FDA and DEKRA submissions.
Provides design quality support in resolving PIRs, CAPAs, non-conforming product, VIPs, and regulatory requirement changes.
Understanding of Design Assurance requirements to support marketed product, product development, design changes and technology transfers and to ensure activities comply to all internal and regulatory requirements.
Provide detailed assessments of impacts for design and process changes on commercialized products Collaborate in development and execution of Design Verification plans, protocols and reports for new and commercialized products as a member of multi-functional team activities through the life cycle of the product from concept, development, commercialization and end of life phases Risk Management: Familiarity with requirements of ISO 14971 Manage and update the products risk management files Contact Information For a confidential discussion or to find out more, please contact: Rachel Mc Mahon Email: Phone: INDCRG Skills: R&D Design Assurance MDR