Graduate Quality Engineer

Overview

ICS Medical Devices specialises in designing, prototyping, and producing cutting-edge catheter-based medical technologies. This role, Graduate Quality Engineer, is integral to the Quality team, assisting in upholding the Quality System and ensuring adherence to Customer, Regulatory, and Quality System standards.

Key Responsibilities

• Oversee multiple quality-related tasks with strong organizational skills and acute attention to detail.
• Collaborate closely with product development teams and clients to define product specifications and requirements.
• Manage and finalize Non-Conformance reports ensuring compliance with timelines and quality benchmarks.
• Support quality assurance aspects of new product launches.
• Gather, compile, and communicate quality metrics effectively.
• Assist in regulatory, internal, and customer audits preparation and execution.
• Participate in equipment and process validations including creation and updating of Master Validation Plans (MVP).
• Conduct audits under the Practice Versus Procedure Program according to schedule.
• Manage quality engineering processes throughout production stages including validation, testing, and ongoing product/process performance monitoring using statistical sampling methods.
• Promote and nurture a quality-centric culture within the organization, delivering relevant training and guidance on standards and requirements.
• Provide manufacturing line support by offering quality expertise related to production issues and product disposition.
• Engage with suppliers to ensure their adherence to company quality standards.
• Conduct induction training along with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) training sessions.
• Assist with Change Control processes and perform other tasks as needed.

Preferred Qualifications and Education

• A degree in Quality, Science, or Engineering is preferred.

Desired Experience and Skills

• Prior exposure to medical device or pharmaceutical environments is favourable.
• Familiarity with FDA and ISO quality systems specific to medical device companies.
• Proficiency in MiniTab or comparable statistical software alongside Microsoft Office suite including Outlook, Word, Excel, Visio, PowerPoint, and Teams.
• Strong communication skills to effectively liaise with engineering teams, management, vendors, and customers.

Behavioural Qualities

• Maintain professionalism and courtesy with colleagues and clients at all times.
• Exhibit dependable punctuality and reliable attendance to support production schedules and team cohesion.

Additional Preferences

• Experience working in fast-paced Small or Medium Enterprises (SMEs) or start-up environments is advantageous.