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Device development assurance specialist

Dublin
beBeeDevelopment
Posted: 12 July
Offer description

Job Opportunity

We are seeking a highly skilled and experienced Principal Device Development Assurance Scientist/Engineer to join our team.


Job Description

The role will be responsible for providing guidance and support for device development programs through the design and development lifecycle. This includes ensuring compliance with design control requirements, establishing and maintaining Design History Files, and collaborating with affiliate sites and third parties.

The ideal candidate will have a strong understanding of Quality Management Systems, relevant regulations, and international standards. They will also possess excellent communication and problem-solving skills, as well as the ability to work effectively in a multi-disciplinary team.


Required Skills and Qualifications

* Education: Degree or Masters in engineering or science/life science
* Industry: Medical Device or Pharmaceutical (with devices)
* Minimum 5-7 years' experience in similar level or 5-10 years' general experience in industry
* Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
* Experience in implementing device design controls and ISO/FDA requirements
* Strong problem-solving and analytical skills


Benefits

Our company offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others. Some of our benefits include:

* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension


Sustainability at Our Company

Corporate social responsibility is fundamental to our mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life.

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