Quality Systems Technical Assistant

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.

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