Quality Assurance Specialist

Full Job Description

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.