Graduate Quality Engineer

Job PurposeGraduate Quality Engineer – Job Description At ICS Medical Devices, we design, prototype, and manufacture innovative catheter-based medical device technology. 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. Working within a cross-functional team, the Graduate Quality Engineer helps maintain high quality and performance standards across multiple production lines, supporting activities such as validation, testing, receiving inspection, and final release. The role also contributes to ensuring products meet all quality, compliance, design control, risk management, change control, and regulatory requirements. Key Responsibilities

• Ability to manage multiple activities with excellent attention to detail organisation skills.
• Work 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.
• Provide manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition.
• Deal with suppliers and ensure their quality standards are in line with company standards.
• Induction Training, GMP and GDP Training.
• Supporting Change Control.
• Perform other related duties as required.

Preferred Qualifications And Education

• Degree in Quality or Degree in Science / Engineering.

Preferred Experience, Skills Competencies

• 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.

Key Behaviours

• Always be professional and courteous with fellow staff and customers.
• Reliable timekeeping and strong attendance are essential to meet production timelines and ensure smooth team operations.

Desirable

• Experience working in a fast-paced SME or start-up environment.