Senior Design Assurance Engineer
Our client, a medical device company, is currently seeking a Design Assurance Engineer to join their Quality Assurance/Regulatory Affairs department. The role is responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.
Role/Responsibilities
Performs Design Assurance activities including technical reviews of design documentation and labeling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
Project manager EU MDR deliverables.
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.
Implement updates to applicable quality system requirements.
Methodical review approach and be capable of initiating and leading change and continuous improvement.
Education/Experience
A 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.
Excellent verbal and written communication skills.
Must have attention to detail for this Quality role.
Training in risk management, problem solving methods, design controls, validations, usability or biocompatibility would be advantageous.
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