Our client a Major Multinational here in Galway are now recruiting Design Assurance Engineers (I/II).
You will demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. The key to the success of this function is to support the application of Design Controls in Product Development and Sustaining Changes to ensure that all design changes are compliant with associated Regulations and Methods.
- Familiarity with requirements and procedures that govern medical device Design Control
- Understanding of Design Assurance requirements to ensure new product/technology transfers comply with all internal and regulatory requirements.
- Collaborates with cross-functional, global teams to support execution of ICH stability studies for development, commercialization, and post-approval commitments of drug-device combination products.
- Provides design quality support in resolving PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
- Concludes and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
- Development and execution of stability plan, protocols and reports for drug-device combination products as part of Design Verification activities through the life cycle of the product.
- Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment provide technical and quality systems input.
- Assure completeness and quality of documentation associated with stability studies (including test data, inventory records, investigations, and deviations) and generate stability packages in conjunction with Project Teams and Reg Affairs for product approval submissions.
- Provide detailed assessments of stability impacts for design and process changes on drug-device combination products, including drug substances, novel excipients, and release controlling polymers
- Coordinate and contribute with analytical test laboratories and teams for product investigations, OOS, OOT and significant change events.
- Ensure and maintain regulatory compliance with appropriate guidance documents - company SOP/WIs, cGMPs, EU/FDA/Global and ICH guidelines for stability studies.
- Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives, and continually seeks to drive improvements in product and process quality
- NFQ Level 8 qualification in a STEM discipline
- Minimum of 3-4 years experience in a Design Assurance capacity.
- Good technical capabilities, communication skills, teamwork abilities, and initiative.
- You have a proven ability to work well both as part of a team and work on your own with minimum supervision.
- You have a proven ability to work well as part of a team & on your own with minimum supervision.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717