Design Assurance Engineer
Sigmar Recruitment
Galway
Design Assurance Engineer. The Design Assurance Engineer ensures that R&D projects are executed in accordance with industry standards and that appropriate product verification and validation activities are implemented to support marketing applications for the device(s. Responsibilities: Work within the Quality System ensuring that the quality policy and company systems and procedures are complied with, in line with FDA Quality Systems Regulations, ISO 13485, ISO14971 and all relevant standards. Support R&D in the preparation and delivery of Design Reviews and associated checklists. Establish and maintain the Design History File and associated documents. Provides design quality support in the resolution of complaints investigation, CAPAs, regulatory requirement changes. Conduct education and training with team members to ensure that best-in-class levels of compliance are maintained. Keep up to date on best practices and constantly seek to improve compliance and efficiencies in line with best practices. Experience: Degree in Engineering/Science or related discipline. Minimum 3 years’ experience in a relevant role in the medical device industry. Experienced with ISO14971 Risk Management Systems. Advanced knowledge and experience with medical device regulated design control systems including advanced knowledge of design verification and validation methods. Highly developed written and verbal communication skills. Proven ability of working in a cross-functional team environment. Knowledge and practical experience with the use of statistical techniques in design verification and validation. Training and experience in auditing (internal auditing, supplier auditing or similar. Strong communication and presentation skills are desirable. Thinks Critically and Makes Sound Decisions. Collaborates and Creates Alignment as a Team member. To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E: chloe.walsh@sigmar.ie All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent.
1108 days ago