Design Quality Engineer

Roc Search is currently recruiting for a Design Quality Engineer.

Must have experience in FDA QSR requirements, ISO 13485.

The DQE responsibilities include:
*Attend design/technical reviews which may include code reviews and technical analyses, change impact analysis, risk analysis and regression test analysis
*Project deliverables - review project documents such as project plans, requirements, design documents, labeling documents, test plans, pre and post execution test cases/protocols, test summary reports, predicate CAPAs and generation of CAPA and complaints report
*Risk management - Conduct/facilitate product and risk assessment for change requests. Experience with DFMEA/PFMEA and hardware knowledge is desirable
*Others - Monitor project progress, attend project meetings and provide quality perspective in decision making process, and ensure the integrity of Design History File (DHF)
*Monitor product release to ensure the applicable process is followed
*Complete training on all applicable assigned company procedures and maintain training status up to date

Skills required
*Should have Engineering degree or equivalent experience in Design Control, Risk Management and Design Verification/Validation of software medical devices.
*The person should have working understanding of ISO 14971:2012, ISO 13485:2012, 21 CFR 820.30 (design control) and other international standards.
*Should have working knowledge of CAPA systems, Risk Analysis and DFMEA/PFMEA
*Should have experience in a FDA or other regulated environment.
*Knowledge of Quality Center or equivalent tool is a plus.

Type: Contract
Location: Edinburgh
Duration: 6 months+
Rate: Dependent on experience

Apply now for immediate consideration to Stuart Chappell at Roc Search.

As a professional company we gladly welcome applications from persons of any age and background and do not intend to discriminate with advert text and terminology.