This position is no longer open for applications

Quality Assurance Specialist

Bootle

Monday to Friday

Competitive salary, please ask for more information Pension, Life Assurance, Healthcare, Holidays

My client, a market leader within their industry, is looking for a Quality Assurance Specialist to support their QARA department. This role plays a key part in maintaining product, process and regulatory compliance across the business. With strong growth, investment and a collaborative culture, this is an excellent opportunity for an experienced QA professional to make a real impact within a highly regulated and rewarding industry.

Role Description

• Support the QARA Manager/Team Leader in maintaining and improving the Quality Management System in line with ISO 13485, ISO 9001 and IVD regulatory requirements
• Monitor, evaluate and enhance product and process quality, including developing and executing QA procedures and test plans
• Lead investigations into product and service complaints, ensuring root cause analysis, corrective actions and customer communication are completed effectively
• Collaborate cross‑functionally to resolve quality issues, support CAPA activities, and contribute to continuous improvement initiatives
• Maintain accurate QA documentation, support vigilance activities, and assist with technical documentation alongside R&D and Quality Control teams

Skills and Qualifications

• Strong understanding of Quality Management Systems and applicable standards (ISO 13485, ISO 9001) and/or medical device regulatory requirements
• Experience working within a regulated environment, ideally IVD, medical device or life sciences
• Knowledge of QMS processes including audits, CAPA, validation, verification and document control
• Experience with complaint handling, root cause analysis and corrective/preventive action processes
• Strong communication skills with the ability to work cross‑functionally and manage customer interactions professionally
• Ability to analyse data, identify trends and drive quality improvements

Company Information

As a business, our client is a true market leader with a strong presence across the UK. With a secure portfolio of customers and continued investment, this role offers long‑term stability and excellent development opportunities within the current economic climate.

In return for your commitment, my client offers a stable and secure career for motivated quality professionals. Please click the link to apply.