Posted: 29 January
Offer description
Job Title: Medical Device Quality Assurance Engineer
A highly skilled Medical Device Quality Assurance Engineer is sought to join a leading company in the medical industry. The successful candidate will be responsible for ensuring that all aspects of product development and manufacturing comply with regulatory requirements.
Responsibilities:
1. Risk Assessments, Device testing and associated validations;
2. Audits (internal and external), Support as SME for design processes;
3. Generation and/or approval of technical documents on behalf of the Quality Function;
The successful engineer will also work effectively as part of product development team in identifying translating user requirements into design requirement ,identifying critical features components contributing towards or leading generation Risk Management Documents Associated quality documents reports etc.[1],Complete Design Verification Validation Test Method Validation Activities Associated With Product Development Works R&D Manufacturing Engineering translating design requirement Into Manufacturing Requirements Including Development Of Manufactuing Test Methods And Implementation appropriate production Process monitoring activites Leads resolution project issues by working Team Members Suppliers Others As Appropriate Generate Review Approve Operational test validation data Associated Equipment Materials Components sub assemblies Final Product Provides Technical Guidance team members technicians inspection staff System Administrator Minitab Ensure Compliance qms per QM001 quality manual Essential Skills Experience minimum Bachelor's Degree engineering Science related field years QA experience Strong Knowledge FDA CFR Part ISO EU regulations Excellent Communication Leadership problem Solving Skills
