Senior Design Assurance Engineer Opportunity
The client is seeking a senior design assurance engineer to join their quality assurance and regulatory affairs department. This role will be responsible for medical product design assurance, design controls, product and process validation system, and risk management activities.
The successful candidate will perform design assurance activities including technical reviews of design documentation and labelling, attend design reviews, coordinate and facilitate completion and update of design risk management documentation and act as an independent reviewer for all design activities including design changes.
They will also project manage EU MDR deliverables, support MDR projects as deemed necessary by the QARA Department, and provide quality approval on all relevant records, tests, validations, reports, project file entries etc.
Additionally, they will support external audits including notified body and FDA audits, promote awareness of regulatory and customer requirements throughout the organization, perform standards gap analyses as required for MDR, R&D projects etc.
They will lead data analysis best practice including sample planning, reporting and statistical analysis, implement updates to applicable quality system requirements, and have a methodical review approach and be capable of initiating and leading change and continuous improvement.
This role requires 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, and excellent verbal and written communication skills.
A strong attention to detail is essential for this quality role. Training in risk management, problem solving methods, design controls, validations, usability or biocompatibility would be advantageous.