Quality Assurance Specialist

5 days ago


Newtownards Co Down, United Kingdom Eakin Healthcare Full time £26,000
About the Role

A key member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.

Key Responsibilities
  • Involved in the creation, improvement, and maintenance of regulatory compliant Quality Management System (QMS) documentation and training thereof.
  • Reviewing and actioning feedback from customers, and supporting the creation, revision, and maintenance of Operating Procedures, Quality Forms, and Work Instructions.
  • Supporting QMS studies and reports, including stability studies, and identifying, investigating, and documenting product and process non-conformances.
  • Collaborating with the Quality Manager to ensure the timely release of finished medical devices and supporting the accurate completion, retention, and review of product release documentation.
  • Informing and collating quality feedback data, and supporting internal audits under guidance from the QHSE Auditor or Quality Manager.
Requirements
  • Minimum of 5 GCSEs or equivalent, including Math and English, and/or a minimum of three years' experience in a medical device manufacturing environment.
  • Proven experience in a volume manufacturing regulated environment in a Quality-based role, with compliance experience to a quality standard.
  • Strong interpersonal and communication skills, with the ability to quickly build effective professional working relationships.
  • Meticulous with high levels of attention to detail, and a strong command of written English.
  • Excellent verbal communication skills, and excellent organisational and planning skills to deliver efficient QMS-based outputs.
Desirable Skills
  • Experience of working in a product/batch release role in the medical device/pharmaceutical industry.
  • Experience of working in a regulated manufacturing environment, such as ISO13485, ISO14971, MDD, EU MDR, MDSAP.
  • Experience of using an electronic quality management system (eQMS), and good documentation practices (GDP).
  • Experience in a medical device/life sciences environment, and experience of using problem-solving and root cause analysis tools.
Working Relationships
  • Internal: R&D to ensure quality and regulatory requirements are met during new product introduction projects, and Production to liaise with production personnel at all levels to ensure requirements for quality are defined and met.
  • External: Dealing with suppliers to discuss quality-related issues and improvements, and dealing with customers and third-party auditors during quality audits.
Additional Information

Occasional travel to other companies within the group and to supplier premises may be required.



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