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Quality Assurance Specialist

Wembley, England, United Kingdom

Job Summary

QA Specialist is responsible for ensuring continued compliance of the Quality Management

System of the company with the relevant Medical Device Directives, Medical Device Regulations,

International Standards, and Customer Requirements and that this is maintained and

implemented accordingly.

Responsibilities

Provide day-to-day support and be responsible to maintain the effectiveness of the

Quality Management System, including, but not limited to, Document Control, CAPA,

Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier

Monitoring and Assessment and Product Release activities

Contribute to strategic improvement projects to improve business processes in line with the applicable regulatory requirements and Medicareplus Regulatory Strategy

Prepare and present Quality Data to analyse quality trends and support investigations,

remediation and improvement initiatives

Accountabilities

Maintain current knowledge base of existing applicable and emerging regulations, standards, or guidance documents

To support and participate in the development of effective and efficient documented

ways of working for the verification of all quality related activities associated with the

manufacture of outsourced raw materials and finished products.

To collate and review batch records, certificates of analysis/conformance, sterilisation

data from subcontractors to ensure that products are made available for sale in

accordance with agreed lead-times

To participate in the effective management of Customer Complaints, Regulatory

Reporting, Non-Conformances and CAPA

To prepare and analyse data for the purpose of Management Review

To ensure that all Change Control activities are effectively controlled, and outputs are

correctly translated into documentation

To ensure that the Labour Standard Assurance System and the Modern-Day Slavery Act

are effectively managed, and all requirements met

To participate in and support internal, supplier and external audit programme

Write or update Standard Operating Procedures and work instructions

Support the RA function as directed

Key challenges

Maintain frequent contact with external sub-contract manufacturers and suppliers

To collate data from multiple sources, interpret and produce meaningful quality

reports with justified and balanced evidence and proposal for remediations as applicable

To work to tight deadlines and manage a workload which has designated lead times

To show initiative in problem solving by identifying and recommending solutions to

problems encountered

To maintain a personal knowledge of the current Quality Management System and

Regulatory Requirements

Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility.

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Quality Assurance Specialist jobs in Wembley, England, United Kingdom

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