Quality Engineering Manager

At IDE we love working with our partners to build better futures. We have worked on over 500 projects across the medical technology landscape, including in the areas of respiratory care, drug delivery, connected medical devices and point-of-care diagnostics.

Making a difference is what matters to us. We create meaningful outcomes by living our values: be resourceful, be curious, think positive, put others first, embrace complexity and take ownership.

• Our engagement surveys over the last 3 years have revealed that our people love working with us for: The people - intelligent people, collaborating together in smart ways to bring products to life
• Our purpose - every day we work at IDE is an opportunity to build better futures
• The variety of projects and intellectual challenges

We are seeking a Quality Manager who is a proactive, passionate team player, driven by solving complex challenges. You’ll be comfortable in making decisions in an environment of uncertainty, be able to apply critical thinking skills and be willing to challenge the status quo.

To understand, believe and support IDE in carrying out its “Why” - We love working together to build better futures. We use our values, principles and processes to create products and services that create meaningful medtech ventures.

To maintain IDE’s ISO 13485 certified, ISO 9001 and 21CFR820 compliant Quality Management System (QMS) and to drive continuous improvement throughout IDE.

To carry out the objective of the Quality Group at IDE by continually improving IDE’s Quality Management System, ensuring that Quality is championed throughout the organisation, satisfying project stakeholders to produce successful results thereby creating and executing on new business opportunities for IDE and its Clients.

To provide support and guidance on QMS requirements and standards within Product Development and Manufacturing projects.

To work with members of IDE’s Business Units and other Functional Groups to continually develop and improve IDE capabilities, resources and equipment.

Qualifications & Experience

• 7+ years of experience in medical device development and/or manufacturing, applying QMS certified to ISO 13485, ISO 9001 or similar.
• 3+ years of experience working in a senior role within the quality function of a medical technology company.
• Experience working as the Quality Lead on a cross-functional team undertaking a medical device development project.
• Experience in managing a team of people (2+ reports), directing and reviewing outputs from quality or other technical personnel.
• A demonstrated ability to effectively train people on quality management principles and on how to comply with quality management systems.
• A demonstrated ability to perform tasks with very fine attention to detail, demonstrating a passion for efficiency and technical quality in design, development and manufacturing documents, and managing reports to do the same.
• Qualification as a lead auditor and experience in undertaking internal and supplier audits.
• Experience in undertaking risk management and risk analysis activities, including Hazards Analysis and FMEA.
• Experience in undertaking manufacturing planning, quality control and process validation in medical device manufacturing environments.
• Demonstrated experience in Microsoft Office suite (required; Excel, Word, PowerPoint, Project).
• A degree in Engineering (Mechanical, Mechatronics, Biomedical), Industrial Design, Sciences or similar applicable technical discipline.

• Career progression and a strong mentoring program
• Employee benefits including an employee assistance program