Quality Systems Specialist Job at 360 Resourcing Solutions (Keele)

Quality Systems Specialist

360 Resourcing Solutions

Location:
United Kingdom , Keele

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world. To provide resource for maintaining Quality Management Systems (QMS).

Job Responsibility:

Maintaining the Biocomposites Ltd. Quality Management System (QMS) and electronic Quality Management System (eQMS) in accordance with all applicable standards, regulations, and requirements e.g., ISO 13485, MDR, FDA guidance
Administration of the Biocomposites Ltd. electronic Quality Management System (eQMS)
Ensuring audit-readiness of the QMS and eQMS at all times, as well participating in internal and external audits as required
Evaluating latest releases of eQMS software to determine the need for validation of active and upcoming modules and, where applicable, conducting the necessary software validation
Performing gap analysis of updated requirements e.g., global standard, to confirm compliance of our existing QMS and eQMS with the applicable requirements
Providing training across the business for eQMS as required by local training requirements
Collating data from the QMS and eQMS for trending and analytical purposes
Troubleshooting and resolving issues within the QMS and eQMS to support user-specific and business needs. Where necessary, liaising with external software provider to resolve issues within the eQMS
Review of production documentation as part of the site batch release process
Providing general support for activities falling under the remit of the Quality Assurance Manager

Requirements:

Level 5 diploma or equivalent in a scientific discipline (or 3+ years quality/manufacturing/systems role)
3 years previous quality experience (preferably in the same or similar industry, e.g. food/pharmaceutical)
Excellent knowledge and experience of eQMS
Able to deliver training
Organisational skills and an ability to work to tight timelines
High attention to detail
Exceptional team skills
Excellent verbal, non-verbal and written communication skills
Car driver

Nice to have:

Any QA/manufacturing/systems related training
Worked within healthcare (medical devices, food or pharmaceutical) manufacturing
Working knowledge of Quality Management System standards
Understanding of quality assurance within a manufacturing environment
Able to act on own initiative

What we offer:

Company events
Company pension
Employee discount
Free or subsidised travel
Free parking on-site

Additional Information:

Job Posted:
April 20, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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