I D

vor 2 Wochen

Central Coast, Österreich Tideri Jobbörse Vollzeit

At IDE we love working with our partners to build better futures, working 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, and our values of being resourceful, curious, thinking positively, putting others first, embracing complexity and taking ownership to drive successful outcomes.

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 Variety of projects available About the role We are seeking a Quality Associate who is a proactive, passionate team player, driven by solving complex challenges, as no day at IDE is the same.
You'll be comfortable in making decisions based on accurate information, be able to apply critical thinking skills and be willing to challenge the status quo.

This role is in our Connected Care Business Unit where you will report directly to the Business Unit Director.
Your primary role will be as the Quality Leader on product development projects, proactively ensuring that quality is planned for and implemented in projects, satisfying project stakeholders to produce commercially successful results.

You will also assist the Quality Manager in the management and improvement of IDE's ISO 13485-certified Quality Management System, ensuring that quality requirements are met throughout Product Development projects, and supporting manufacturing activities.

Key Responsibilities Include:

Leading the Quality function as Quality Lead on product development cross-functional teams.
Supporting strategy development and planning of projects.
Proactively supporting the scaling of processes to meet the needs of various projects.
Identifying and implementing training needs.
Provide review and approval of project deliverables.
Monitoring compliance of project activities with QMS requirements.
Sharing knowledge across the business.
Supporting maintenance and improvement of the QMS in accordance with ISO 13485, 21CFR820 and ISO 9001.
Carry out internal audits and spot checks.
Continuous improvement of the quality framework to meet the needs of the business.
Actively collect, analyse and communicate data on the QMS.
Manage the control of QMS documentation and records.
Create and update QMS documentation including SOPs.
Train product development employees in IDE's processes and quality management principles.
Support in management of key QMS processes including equipment calibration, supplier qualification, and CAPA.
Completion of allocated tasks to the specified level of quality and within agreed timeframes and budgets.
About you A degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or similar applicable technical discipline.
Minimum 2 years' experience working in medical device development projects in a functional leadership role.
Experience working in an ISO 13485-compliant QMS.
Understanding of key Medical Device standards including ISO 14971 and IEC 62366.
Desired Skills and Experience:

Experience in undertaking manufacturing planning, quality control and process validation in medical device manufacturing environments.
Strong Microsoft Office skills, particularly Word and Excel.
Why IDE Career progression and a strong mentoring program Flexible working options available Employee benefits including an employee assistance program Ready to join the team?
If you are ready to be challenged but fulfilled, and have the right skills, experience and, most importantly, the right attitude, then a truly unique role in a life-changing product development company awaits.
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