Quality Assurance Specialist
3 days ago
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.
Key Responsibilities:- Involved in the creation, improvement, and maintenance of regulatory compliant Quality Management System (QMS) documentation and training thereof.
- Support creation, revision, and maintenance of Operating Procedures, Quality Forms, and Work Instructions.
- Identification, investigation, and documentation of product and process non-conformances, document root cause, and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements.
- Support and execute the timely release of finished medical devices to ensure schedules are maintained and stock available.
- Support and coordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders and ensuring all product release documentation complies with the appropriate site regulatory certification and standards (ISO13485, MDSAP, GMP, GDP, FDA CFR).
- Inform and collate quality feedback data ensuring that key information is relayed to the Quality Manager.
- Support and perform internal audits under guidance from the QHSE Auditor or Quality Manager.
- Assisting the Quality Manager with the achievement of annual objectives as directed.
- Collate and trend quality metrics and suggest improvement activities as required.
- Support and assist third-party audits and inspections across Eakin Healthcare as required.
- In conjunction with other departments, ensure all reported Customer Complaints are acknowledged, investigated, and reported within Target Closure timelines.
- Collaborate and own Corrective and Preventative Actions, Customer Complaints, Non-Conformances, and subsequent product dispositions e.g. product rework administration.
- Log and measure QMS and product Key Performance Indicators, demonstrating QMS effectiveness.
- Ensure product quality standards are met by implementing inspection and testing protocols on products within all production, goods in, and warehousing.
- Ensure inspections are performed in compliance with QMS documentation and that the inspections are being recorded accurately.
- Report all Quality-related issues to the Quality Manager.
- Comply with QMS requirements for wearing the correct protective clothing as outlined in the relevant QMS documentation.
- Ensure testing requirements are met at all stages of the production process and that appropriate documentation is maintained.
- Ensure accurate records of any inspection and test activity are completed and forwarded to the Quality Manager for review against specified targets.
- Develop a thorough knowledge of the Operating Procedures, Work Instructions, and Quality Forms relevant to the various Production areas and Goods In.
- Assist the Quality department with Quality System/Product development administration tasks as required.
- Provide accurate data relating to inspection levels for analysis by the Quality Manager.
- 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 command of written English.
- Excellent organisational and planning skills to deliver efficient QMS-based outputs.
- Competent in the use of Microsoft Office.
- Experience of working in a product/batch release role in the medical device/pharmaceutical industry.
- Experience of using an electronic quality management system (eQMS).
- Experience in a medical device/life sciences environment.
- Experience of using problem-solving and root cause analysis tools (8D, FMEA, etc.).
- Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues.
- Experience in development of training materials and delivery of training presentations.
- Quality auditing certification.
Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.
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