Job Title: Graduate Quality Engineer
Reporting to: Quality Manager
Job Description
- The Graduate Quality Engineer will be a member of the Quality team and will support maintenance of the Quality System, ensuring compliance to Customer, Regulatory and Quality System Requirements.
- The activities will include, but are not limited to, maintaining quality system metrics, supporting validation activities, production activities, supporting change control activities and supporting risk management activities.
- The Graduate Quality Engineer will have the opportunity to gain excellent experience and exposure supporting the Quality System, Operations, Design Assurance, Supplier Quality and New Product Introduction (NPI) while supporting projects from product inception through to production. Quality systems team strive to ensure processes within our Quality system (Document Management, Training, Non-Conformance, CAPA, Audit) are effectively followed and requirements are met. Supports the generation and identification of key metrics. Compiles, evaluates and presents quality systems data and metrics.
- The Graduate Quality Engineer will be working as part of a team to maintain high quality / performance standards across multiple production lines, from receiving inspection to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance.
- he Graduate Quality Engineer will play an active role in the processes to ensure products meet quality and compliance standards regulations while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements.
Responsibilities
- Ability to manage multiple activities with excellent attention to detail & organisation skills.
- Works closely with product development engineering and the client team to establish the product specifications and product specific requirements.
- Own and manage completion of Non Conformance reports with a high level of quality, ensuring to meet timeline metrics.
- Support new product introduction from a QA perspective.
- Compile and report quality metrics.
- Support regulatory, internal and customer audits.
- Support equipment and process validation activities including generation / updates to MVP.
- Support Practice Versus Procedure Program, completing audits as per schedule.
- Manage quality engineering activities from receiving to final release, including but not limited to validation, testing, and continuous monitoring of product/process performance using applicable sampling and statistical techniques.
- Support Quality culture within the organisation while providing training and guidance on applicable requirements / standards.
- Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition.
- Deals with suppliers and ensures their quality standards are in line with company standards.
- Induction Training, GMP and GDP Training.
- Supporting Change Control.
- Perform other related duties as required.
Requirements
- Degree in Quality or Degree in Science / Engineering.
- Experience within the medical device or pharmaceutical environment desirable.
- Knowledge of FDA and ISO Quality systems for Medical device companies.
- Knowledge in MiniTab (or equivalent statistical software) and Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams.
- Strong interpersonal skills and the ability to communicate appropriately with different engineering teams, management, vendors and customers.