Quality Assurance Specialist

1 week ago

Newtownards, United Kingdom Eakin Healthcare Full time
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 key role in the Operations Compliance Team, provide business support and guidance in line with Compliance and Eakin Healthcare Strategies.

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, supporting the creation, revision, and maintenance of Operating Procedures, Quality Forms, and Work Instructions.
  • Supporting QMS studies and reports, identifying, investigating, and documenting product and process non-conformances, and liaising with relevant departmental representatives.
  • Supporting the timely release of finished medical devices, ensuring schedules are maintained and stock available.
  • Supporting and coordinating the accurate completion, retention, and review of product release documentation, liaising with internal stakeholders.
  • Informing and collating quality feedback data, ensuring key information is relayed to the Quality Manager.
  • Supporting and performing internal audits under guidance from the QHSE Auditor or Quality Manager.
  • Assisting the Quality Manager with the achievement of annual objectives as directed.
  • Collating and trending quality metrics, suggesting improvement activities as required.
  • Supporting and assisting third-party audits and inspections across Eakin Healthcare as required.
Key Skills
  • Minimum of 5 GCSE or equivalent, including Math and English, and/or a minimum of three years experience in a medical device manufacturing.
  • 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, able to quickly build effective professional working relationships.
  • Meticulous with high levels of attention to detail, strong command of written English, and excellent verbal communication skills.
  • Excellent organisational and planning skills to deliver efficient QMS based outputs, proactive and able to work unsupervised.
  • Ability to work well in a team, competent in the use of Microsoft office.
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 (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP).
  • Experience of using an electronic quality management system (eQMS), good documentation practices (GDP), and experience in a medical device/life sciences environment.
  • Experience of using problem-solving and root cause analysis tools (8D, FMEA etc.), implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions.
  • Experience in development of training materials and delivery of training presentations, quality auditing certification.
Working Relationships
  • Internal R & D to ensure that quality and regulatory requirements are met during new product introduction projects.
  • 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, dealing with customers and third-party auditors during quality audits.

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