The Quality Engineer plans, coordinates, and manages the activities associated with one or multiple Product Development projects to ensure compliance with internal and external requirements during development of Medical Device products, or lifecycle management of existing products.
As part of a project team, the PDQE is responsible for developing sound Design History File deliverables.
Main duties and responsibilities:
- Provide focused engineering support and assume responsibility for timely and effective coordination and/or execution of assigned design control project activities.
- Responsible for working with QRA and Projects team to create and execute design development plans for new products.
- Work closely with the QRA department to ensure regulatory implications of any new product design etc. are clearly understood and accounted for in the development process
- Manage stage gate process for development projects
- Assure that all applicable elements and product technical standards are effectively incorporated into new designs and into changes to designs.
- Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products.
- Writing and updating design control documentation to ensure design traceability.
- Lead design reviews through the design process.
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Lead and/or support Risk Management activities, for new and/or modified products which includes ensuring that risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
- Support quality team on process validation to ensure successful design transfer into manufacturing.
- Participate in supplier selection process for development projects and component specification reviews to ensure that purchased items meet specifications.
- Responsible for design verification planning and reporting.
- Support on biocompatibility assessment for new products or changes in design.
- Deliver design outputs to QRA to ensure compliance of product for successful registration and launch.
- Support quality system and implementation product life cycle. Work with colleagues to support quality disciplines, decisions, and practices to ensure continual improvement.
- Lead design change activities for CE marked products, supporting product lifecycle and post market surveillance activities.
- Involvement in internal audits, external audits and risk assessments for design and development aspects, taking corrective actions where necessary.
- Working with colleagues in the Quality team to implement Product Quality practices and procedures compliant with relevant standards including ISO 13485:2016 and CE Marking for medical devices
- Bachelor's degree in Engineering or Science or related scientific discipline, or equivalent
Experience and Skills
- Minimum of 5 years medical device development experience or equivalent experience within a device or pharmaceutical company, CRO, or similar organization
- Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
- Excellent report writing skills
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate Proactive, high performance, result oriented and manage projects with ethical integrity
- Technical system skills (e.g. MS office applications, databases, efficient online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary
- Demonstrate both creative and critical thinking skills
You will be rewarded with a great salary and benefits, and the onward opportunity to develop your career. Our client is currently shortlisting for interview, so please apply at your soonest convenience.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.