Quality Systems Technical Assistant

Artis Recruitment; Cardiff; Hybrid; GBP 25,000 - 35,000; Full time

Job summary

A leading recruitment agency is seeking a Quality Systems Technical Assistant in Cardiff. You will support various quality assurance activities while ensuring compliance with industry standards. Ideal candidates have experience in medical devices or pharmaceuticals, strong organisational skills, and the ability to manage documentation effectively. This role offers a hybrid working model and competitive benefits including an annual bonus and private medical insurance.

Benefits

Annual bonus scheme

Private medical insurance

25 days annual leave plus bank holidays

Life assurance (4x salary)

Qualifications

• 1+ years experience in a regulated industry such as medical devices or pharmaceuticals.
• Familiarity with ISO13485, MDR 93/42/EEC, and FDA QSR Part 820 is desirable.
• Experience with investigational quality activities.

Responsibilities

• Monitor changes within the Product Lifecycle Management (PLM) system.
• Assist in CAPA, NCR, and complaints management.
• Support quality activities to ensure compliance.

Skills

Strong organisation and prioritisation skills

Excellent communication skills

Good attention to detail

Proactive team player

Education

GCSE level qualification (Science/Engineering/Quality) or equivalent

Tools

Microsoft Office (Word, Excel)

Electronic change control systems

Job description

Overview

Quality Systems Technical Assistant to join a well-established Quality Systems department within a leading organisation who design and develop medical devices. This is a varied role, providing technical support to ensure quality standards and regulatory requirements are consistently met.

The successful candidate will play a key role in supporting documentation, change control, non-conformance management, product release, training systems and wider quality assurance activities.

Key Responsibilities

• Progress and monitor changes within the Product Lifecycle Management (PLM) system in line with established quality procedures.
• Manage documentation and support control processes to maintain compliance.
• Assist in quality activities relating to corrective and preventive actions (CAPA), non-conformance reports (NCR) and complaints.
• Support the Quality Systems team in reviewing documentation for products manufactured or serviced to ensure regulatory compliance.
• Maintain and oversee the Electronic Training System to ensure quality requirements are met.
• Provide guidance to design and manufacturing teams on the Change Control process to minimise future risk.
• Generate reports for management to monitor system performance.
• Contribute to improvements within the Quality System to drive efficiency while remaining compliant with industry regulations.
• Support and deliver training across the business to raise awareness of quality requirements.

Skills & Experience Required

• GCSE level qualification (Science/Engineering/Quality) or equivalent proven experience.
• At least 1 year’s experience in a regulated industry such as medical devices, pharmaceuticals, or similar.
• Knowledge of electronic change control systems and experience with investigational quality activities.
• Familiarity with ISO13485, MDR 93/42/EEC and FDA QSR Part 820 (desirable).
• Competent with Microsoft Office (Word, Excel) and MRP systems.
• Strong organisation and prioritisation skills, with the ability to manage multiple tasks.
• Excellent communication skills, both written and verbal.
• Good attention to detail with accurate record-keeping abilities.
• A proactive team player who works with integrity and accountability.

Benefits

• Hybrid working model (typically 2 days from home, 3 days on-site).
• Annual bonus scheme.
• Competitive pension contributions.
• Life assurance (4x salary).
• Private medical insurance.
• BUPA dental cover.
• 25 days annual leave plus bank holidays.
• Employee Assistance Programme.