Quality Engineer II (Design Assurance)

Job Title:
Quality Engineer II (Design Assurance)
Location:
Galway-Permanent
Industry:
Medical Device
Company information:
Galway’s 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@cregg.ie to discuss.
Qualifications / Professional Skills / Knowledge

• Degree required: Level 7 or 8 Degree in a STEM discipline
• Minimum of 2-3 years experience in a Design Assurance/Quality/R&D/Production capacity.
• Good technical capabilities, communication skills, teamwork abilities and initiative.

Key skills or qualifications:

• General:
  • Supports stability studies from start to finish (development of stability protocol, collaboration with the analytical lab for stability results from different timepoints, stability datasheets, stability data verification, development of stability report etc.)
  • Supports the approval of FDA pre-sub, FDA and DEKRA submissions
  • Knowledge of materials (polymers and metals), drugs, sterilization of medical devices.
  • Provides design quality support in resolving PIRs, CAPAs, non-conforming product, VIPs, and regulatory requirement changes.
• Design Control:
  • 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 product’s risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.

Contact Information
For a confidential discussion or to find out more, please contact:
Rachel Mc Mahon
Email: rachel@cregg.ie
Phone: 0860127415