Job Description
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
The Design Assurance Quality Engineer is responsible for maintaining compliance of the IVD and Medical Device product portfolio to the applicable Design Control, Quality and Regulatory standards.
Key Responsibilities:
- Ensure product documentation is maintained in compliance to the latest Design Control procedures, Quality and Regulatory standards
- Support the execution of the Medical Device Regulation project for Class IIa Medical Devices.
- Ensure products are maintained throughout the full product lifecycle, from product launch to post market surveillance in compliance with global standards and latest state of the art requirements.
- Responsible for completing Design Change Assessments for Change Controls impacting regulated products.
- Support the introduction/implementation of product/process/materials changes to the manufacturing operation.
- Ensure that product/process/package/label/Test Method designs and associated documentation comply with applicable Standards and Regulations for products distributed globally.
- Support internal and external audits and regulatory inspections.
- Collaborate with Reg Affairs and Marketing to provide necessary product documentation for Regulatory submissions.
- Maintain Technical Documentation including Standards assessments, Usability, Post-Market Surveillance, Risk Management and Design Verifications.
Who you are
- Degree in an appropriate science or engineering discipline and at least 3 years relevant experience in the Medical Device/Pharmaceutical industry.
- Excellent written and oral communication skills.
- Self-starter and independent critical thinker, with the aptitude to work autonomously and within a team.
- Experience in Quality tools, ISO13485, ISO14971 and understanding of MDR and IVDR regulations a distinct advantage
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
Apply now and become a part of our diverse team
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