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Quality Officer

Stirling   •  Permanent, Full time


CK Science are recruiting for a Quality Officer to join the Quality Support function of a rapidly growing research and development company in the diagnostics sector. The Shift QA Officer will be working at the manufacturing site near Stirling on a full time, permanent basis.

The Company:
Our client is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. This is an exciting time for them as they go through a period of growth. They are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of their dynamic and forward-looking company.

Quality Officer Role:
Reporting to a Senior Quality Engineer or the Quality Manager, the successful candidate shall be responsible for the day to day QMS activities associated with the production of IVD sensors (assays) and instrumentation with emphasis on providing QA input to manufacturing support, supply chain activities, process validation, complaint investigations and/or product release. Activities such as document/process creation, review and approval of documents, batch release and internal audits are requirements of this role. Effective working with other teams including quality assurance, technical, production, engineering, customer services and supply chain personnel will be required ensuring day to day use of the quality management system in line with the requirements of ISO 13485:2016 and CFR 21 Part 820.

Key Roles and Responsibilities
- Providing quality advice and support to other departments
- QA review of records including quality events, planned deviations, corrective actions, customer feedback, protocols, risk assessments and supplier issues
- QA review of records associated with commercial and/or validation batches including the collation and archiving of all relevant batch records as part of Device History Records
- Update and maintain Device Master Records
- Execution of internal audits
- Collation and provision of data for external audits
- Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
- Collation of data to support the generation of Quality Metrics and KPI\'s
- Support supplier approval and monitoring activities including supplier audits
- Prepare and create documents and records for upload on to the document management system
- Review and approve change controls as Quality representative on project teams and QMS

About You:
Essential skills
- Knowledge and experience of working to the appropriate quality and regulatory standards in a regulated industry
- Experience of working in a relevant role with a strong quality focus and with a minimum of 2 years\' experience, experience working in complaints is highly desirable
- Scientific background
- Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (e.g. document management; complaint; ERP systems

Desirable skills
- Knowledge and experience of ISO13485, FDA 21 CFR Part 820, MDSAP
- Experience of post-launch IVD or medical device activities in a quality role
- Degree preferred
- Trained auditor
- Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)

Apply:
Entitlement to work in the UK is essential. Please quote reference 49589.

INDSPE


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Natalie Wood
  • Phone: 01246 457700
  • Reference: 49589
  • Posted: 10th February 2021
  • Expires: 10th March 2021

CK Group

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