Design Assurance Expert
* A leading medical device company seeks an experienced Design Assurance Specialist to lead their Quality Assurance/Regulatory Affairs team. The ideal candidate will be responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.
* The successful individual will perform technical reviews of design documentation and labelling, attend design reviews, coordinate completion and update of design risk management documentation, and act as independent reviewer for all design activities including design changes.
* They will also project manage EU MDR deliverables and support MDR projects as needed by the QARA Department.
* Quality approval of relevant records, tests, validations, reports, and project file entries is also a key responsibility.
* The role requires strong communication skills to promote awareness of regulatory and customer requirements throughout the organization.
* Standards gap analyses for MDR and R&D projects will be conducted, and the individual will provide guidance and training for new hires and student engineers.
* They will support test development and method validation, lead data analysis best practice, and implement updates to applicable quality system requirements.
* A systematic review approach and ability to initiate and lead change and continuous improvement are essential qualities.
Requirements:
* Bachelor's degree in Engineering, Technology, or Science.
* At least 5-7 years' experience working in a regulated device or pharmaceutical company.
* Excellent planning and coordination skills.
* Strong verbal and written communication skills.
* Attention to detail is crucial for this Quality role.
* Training in risk management, problem-solving methods, design controls, validations, usability, or biocompatibility would be beneficial.
About This Role:
This is a fantastic opportunity for an experienced professional to join a dynamic team and contribute to the development of high-quality medical devices.