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.

Job Summary
To provide resource for maintaining Quality Management Systems (QMS).

Reports to: Quality Assurance Lead
Location: Keele office (IC4/5) & Trentham Warehouse (E2) facility occasionally
Working pattern: Monday–Friday between 8:00am–4:00pm / 9:00am -5:00pm

Duties & Responsibilities

• 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.

Essential 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.

Desirable requirements

• 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 do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Benefits

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