Our client a major multinational here in Galway are looking for a Design Assurance Engineer on an initial 12 month contract.
The key to the success of this function is to fulfil the quality assurance responsibilities of companies product development and post-market (commercial product) support, including 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, Risk Management and Post Market Surveillance.
- Understanding of Design Assurance requirements to ensure new product/technology transfers comply with all internal and regulatory requirements.
- Provide design quality support in resolving PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes.
- Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, Complaints Management Centre and Post Market Quality Assurance team environments to provide technical and quality systems input.
- Evaluate trending and product performance to support site-level Signal Evaluation Reviews and Complaint Review Boards.
- Assure completeness and quality of documentation (including test data, inventory records, investigations and deviations).
- Excellent analytical and problem-solving abilities. Analyse and draw conclusions making appropriate decisions concerning risk management activities.
- Ensure and maintain regulatory compliance with appropriate guidance documents - company SOP/WIs, cGMPs, EU/FDA/Global guidelines.
- Leverage knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- Demonstrate best practices in line with the department and site objectives and continually seek to drive product and process quality improvements.
- NFQ Level 8 qualification in a STEM discipline.
- Minimum of 3-4 years experience in a Design Assurance capacity.
- Experience in post-market (complaints) support, risk management, design and process change, and standards compliance (to regulatory requirements).
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well both as part of a team and work on your own with minimum supervision.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717