At Sigmar Recruitment, we are seeking a Quality Engineer II to join our team on a 12-month contract. As part of a dynamic and supportive team, you will play a pivotal role in supporting the development and implementation of quality systems.
About Your New Job
You will be responsible for supporting design and development initiatives, including design controls, verification, and validation activities. You will also contribute to the development and validation of test methods and computer system assurance programs in line with regulatory requirements.
Your Key Responsibilities
* Support the development and implementation of quality systems
* Collaborate with cross-functional teams to uphold quality policies and objectives
* Participate in risk management processes and usability engineering efforts
* Lead or support investigations and resolutions related to CAPAs and non-conformances
* Monitor and assess changes to relevant standards and guidance documents, conducting gap assessments as needed
* Support supplier quality activities, including selection, evaluation, and maintenance of the Approved Vendor List
About You
* A Level 8 NFQ in Engineering or Science
* Minimum of 3 years experience in medical device manufacturing
* Familiarity with FDA and EU regulatory requirements, including QSR and ISO standards
* Demonstrated ability to manage priorities, solve complex problems, and lead technical initiatives
What We Offer
We offer a collaborative and innovative work environment, opportunities for professional growth and development, and a competitive compensation package.