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Design Control Officer
The Design Quality Engineer will support the design control and risk management activities applied to in vitro diagnostic medical devices and ensure that the design control and risk management procedures are compliant within standards.
- Compilation of design control and risk management documents [design control plan, design inputs, design outputs, risk analysis etc.] required to support the device design history and risk management file.
- Assist in timely completion of design control milestones such as design inputs, design outputs, design verification/validation, design reviews etc.
- Review of analytical validation protocols, data and reports to ensure that they are accurate that they align with design and risk management requirements and internal processes.
- Review product documentation (product proposals, product scope documents etc.).
- Assist in company purchasing controls and where required assist in supplier audit program with the Quality Team.
- Ensure design control and risk management procedures are compliant with IVD Device standards and regulations. Identify, write, approve and implement design control procedures and assist in training as required on new/ revised procedures.
- Actively assist all departments within the product development team with the implementation of design control and risk management activities and ensure that design control procedures are continuously improved with the objective of assuring regulatory compliance and quality of manufactured IVD medical devices.
- Monitor design control and risk management process applied to IVD device design and development. Participate in internal product teams implementing design control activities and ensure that these are being carried out in accordance with internal policies and procedures.
- Assist in product team in design review/design change activities and follow up on actions.
- Support internal audits on design controlled products.
- Maintain document control system for the design control and risk management documents.
- Participate in audits by internal customers and third parties certification and regulatory bodies.
- Promote awareness of design control compliance and provide regular training on the design control process within the company.
Desired Skills & Experience:
- Bachelor degree in Science/Engineering discipline
- Experience of performing design control and risk management activities in accordance with QSR 820, ISO 13485 and ISO14971.
Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.
Gattaca Plc provides support services to Matchtech and may assist with processing your application.
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