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