Senior Design Assurance Engineer required to ensure end products meet all Regulatory and Design Verification / Validation requirements for growing medical devices company in Galway.
An exciting opportunity has opened which you will be reporting to the Design Assurance Manager. The successful candidate will get the opportunity to work in a dynamic team, working on NPD (New Product Development) & Sustaining Projects cross functionally with R&D, Regulatory, Clinical & Manufacturing departments to ensure company products meet all Regulatory and Design Verification / Validation requirements.
- Bachelor’s Degree in Engineering, Technology or Science.
- Minimum 6 years experience working in a regulated device or pharmaceutical company.
- Excellent understanding of MDR, ISO 13485 and FDA QS regulations.
- Excellent understanding of Quality Systems.
- Understanding of Design Control process.
- Training in risk management, problem solving methods, design controls, validations, usability or biocompatibility would be advantageous.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to guide and motivate new hires and student engineers.
- Ability to communicate quality / regulatory concepts effectively.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Must have attention to detail for this Quality role.
- Proficiency in use of desktop software applications such as MS office.
Some travel may be required with the role.
- Performs Design Assurance activities including technical reviews of design documentation and labelling, attends design reviews, coordinates and facilitates completion and acts as independent reviewer for all design activities including design changes.
- Leading the execution of quality deliverables such as Risk Management Plan/Report, Hazard Analyses, SHUMA & DFMEA, Usability Testing, Design Verification, Quality Plans, and Post Market Surveillance
- Support MDR projects as deemed necessary by the QARA Department
- Quality approver on all relevant records, tests, validations, reports, project file entries etc.
- Supports external audits including notified body and FDA audits.
- Promotes the awareness of regulatory and customer requirements throughout the organization.
- Perform standards gap analyses as required for MDR, R&D projects etc.
- QA lead for Product design transfer/validation strategy development and implementation.
- Provide guidance and training for new hires and student engineers.
- Support new test development and appropriate test method validation
- Lead data analysis best practice including sample planning, reporting and statistical analysis.
- Lead & support product usability for new product development and design change projects.
- Implement updates to applicable quality system requirements.
- Methodical review approach and be capable of initiating and leading change and continuous improvement.