Job Title: Quality Assurance Specialist
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The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with our Medical Device client in order to maintain MDR, ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing including secondary packaging activities and Distribution.
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Key Responsibilities include:
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* Aiding the team in the development, implementation, and maintenance of the Quality Management System.
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* Supporting the operation of the Quality Management System & Documentation control such as: Change Controls, CAPAs and Non-conformances, Training, Internal, vendor and third-party audits, participating in product and process risk assessments.
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* Performing Internal Audits or Supplier audits.
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* Performing Supplier Qualification & monitoring as requested.
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* Driving continuous improvement initiatives within the QMS.
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* Partaking in Customer-specific or internal quality projects.
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* Performing QA Verification of activities performed in production.
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* Reviewing and updating Quality System documentation (procedures, Reports) as requested.
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* Partaking in activities for design & process validation.
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* Taking part in Notified Body Audits and Audit preparation as requested.
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* Generating Quality Metric reports as required and assisting in any other data compilation as requested.
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Requirements:
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To be successful in this role, you will need:
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* A Third-level qualification in natural sciences (Certificate, Diploma, Degree level).
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* 3+ years' experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices).
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* Good planning and organizational skills.
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* Good communication (oral and written).
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* A hardworking and highly motivating individual, with good attention to detail.
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Benefits:
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We offer a competitive package including:
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* Pension
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* Healthcare
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* 25 days' holidays
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This is an exciting opportunity to grow your career with a leading Medical Device company working on projects from concept to delivery.
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If you are a motivated and experienced Quality professional looking to take your career to the next level, please apply now.