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QA Document And Change Control Associate

Date: Dec 9, 2021

Location: Dunfermline, GB, KY11 8GR

Company: Optos

QA Document and Change Control Associate

Permanent

 

ROLE SUMMARY

We are currently looking for a QA Document and Change Control Associate to join our Quality Assurance department.

 

The QA Document and Change Control Associate will coordinate design & change control activities, ensuring compliance with medical device regulations.  You will assist in improving and maintaining the existing internal document & change control procedures regulatory standards for all retinal imaging products developed within the New Product Development group.

 

The role encompasses the coordination of Change Control activities within Optos UK, US and Europe.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • 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.

 

MINIMUM 

  • Experience in the requirements of engineering change control, preferably within a medical 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 to produce high quality work.
  • 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.
  • Good computer skills (MS Office applications).
  • Passion and drive to deliver, “must do” attitude.

 

BENEFITS

At Optos, we offer a highly competitive compensation and benefits package.

 

EQUAL OPPORTUNITIES EMPLOYER

We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, age or protected veteran status.

 

If you feel you have the necessary skills and experience and want to join a great team, please click on the Apply button!