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Quality Systems Technical Assistant
Job Posted: a day ago
Salary: £ 30,000 - 34,000 / Annum
Job Type: Permanent
Location: CF1, Cardiff, South Glamorgan
Expire in: a month
Job Description
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 ProgrammeBefore You Apply
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