Design Assurance Quality Engineer (Hybrid)
Design Assurance Quality Engineer (Hybrid)- Galway
Our client a leading medical device company are looking for a Design Assurance Quality Engineer to join their team. The successful candidate will demonstrate commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Support the application of Design Controls and Regulations in Sustaining Engineering and Product Development ensuring that they continue to deliver products of the highest safety and quality to their patients.
- Familiarity with requirements and procedures that govern medical device production and 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.
- Interfaces with Operations teams, R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing quality and technical input.
- Provides design quality support and product assembly knowledge in the resolution of PIRs, complaints investigation, CAPAs, non-conforming product, VIPs and regulatory requirement changes.
- Supporting the company’s transition to EU MDR by collaborating with submissions, reviewing notified body feedback, assisting divisional product teams with submission responses, and acting on feedback trends by driving process improvement projects across the design controls sub-processes
- Provide detailed assessments of impacts for design and process changes on commercialized products
- Acts as an inclusive team member in drawing conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities
- Support internal and external audits and audit responses for commercialized and new 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
- Assure quality and completeness of documentation associated with design verification studies (including test data, manufacturing records, investigations and deviations) and generate submission packages in conjunction with Project Teams and Regulatory Affairs for regulatory submissions.
- Coordinate and contribute with test laboratories and teams for product investigations, OOS, OOT and protocol deviations
- Ensure and maintain regulatory compliance with appropriate guidance documents, – company SOP/WIs, cGMPs, EU/FDA/Global and ICH guidelines for design verification activities.
- Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- Work with cross functional, global teams to support execution of stability studies for development, commercialisation and post-approval commitments of drug-device combination products.
- 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
Education and Experience:
- Level 8 qualification in a STEM discipline (Science, Engineering)
- Minimum of 3-4 years’ experience in a Design Assurance capacity.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
- Proven ability to work well as part of a team & on own with minimum supervision.