Quality Assurance Design and Change Control Associate

Job Description

To coordinate design & Change Control activities, ensuring compliance with medical device regulations. Assist in improving and maintaining the existing internal document & change control procedures regulatory standards for all products developed within theNew Product Development group.Client DetailsApproaching its 30th anniversary and proud to be recognised as a leading provider of devices to eye care professionals to provide a more complete approach to patient care. Developing devices to improve patient outcomes through providing the best retinalimagining technology available. This core purpose is still at the heart of what they do and whichever business area you work in everyone has a part to play and so develops a rewarding career.Description

• Coordinate Departmental Change Boards; representing projects, making sure cross departmental requirements are considered.
• Support in the development of new and existing systems to assist in the requirements for ISO13485 and FDA CFR21 part 820.
• Assisting with the Management of Device Master Records, Device History Files including Risk Assessments, Engineering Change Orders, review minutes and validation protocol and reports.
• Creating and maintaining design history file(s) for all revisions of new products developed.
• For all design changes, managing appropriate risk assessment, engineering change orders and concessions in accordance with regulatory requirements.
• Working with hardware and software teams to ensure that changes are produced, distributed and auditable and that only authorised changes are modified to meet product design changes.
• Working with Supply Chain/Ops to ensure any components affected are identified and they understand the changes and/or requirements.
• Coordinating the design and development phase reviews. Organising and chair the review meetings and ensure appropriate preparatory work is done for the review by all contributors, and that all actions are closed in a timely manner.
• Assist the QA Design & Change Control Team Leader to continually improve Change Control Procedures to reduce waste and streamline development activities
• Supporting manufacturing and operations with change delivery to be efficient and low impact as possible.

Profile

• Significant engineering change control experience, preferably within a medical product development team.
• Knowledge and appreciation of ISO13485 and FDA Medical Device Design Control processes.
• An ability to work within tight deadlines and manage time effectively.
• Team orientated, responsive and customer focused.
• Flexible, persistent, and pragmatic.
• Technically driven with good analytical skills.
• Good written and verbal communication and negotiation skills.
• Strong pro-active communicator with the ability to influence others.
• Ability to produce high quality work under pressure and within tight timescales.
• Good computer skills (MS Office applications).
• Passion and drive to deliver, "must do" attitude.
• To undertake any other reasonable duties and responsibilities as may be required

Job OfferExciting Rewarding Career£25k - £29K DOECareer Progression and Development

Keyskills :
Quality AssuranceQA Design & Change Controlengineering change controlISO13485 and FDA Medical Device Design Control