|Location: Crawley, West Sussex||Salary: £40000 - £45000 per annum|
|Sector: Medical Devices||Specialism:|
|Type: Permanent||Contact: Matt Henocq|
Quality and Compliance Engineer
My client is a global supplier of medical technology for critical care, operating theatre and home healthcare applications. The Quality and Compliance Engineer is responsible for maintaining and supporting the promotion of Quality Assurance and supporting overall compliance. This position provides and contributes to the delivery of Quality Assurance deliverables, providing Quality solutions to business requirements, including internal R&D Projects and changes to the compliance landscape. This position provides operational Quality Assurance input and guidance to cross-functional teams, ensuring compliance to MDSAP and other applicable global standards.
Work with Manufacturers and Suppliers to assure and improve the quality of products and services supplied to my client and its customers.
The role involves all stages of the product lifecycle, using customer, manufacturing and supplier feedback to improve overall Quality.
- Closure of NC's / CAPA in line with KPI's defined in Quality Objectives
- Prepares and submits Vigilance Reports in line with agreed timeframes
- Executes / supports internal and external audits
- Support Notified Body Audits
Main duties of the role:
- Working with Manufacturers and Suppliers to ensure problems are effectively resolved and investigations are fully documented. Effectively contain issues to minimise repeat issues affecting manufacturing and supply chain. Instigate and implement effective corrective and preventative actions (CAPA).
- Continually aim to establish and implement activities which support manufacturing and distribution. Minimise the need for upstream inspection and testing activities.
- Take responsibility for closing identified manufactured and supplier related NC's in a sustainable and timely fashion.
- Working with installed base manufacturers and suppliers to ensure problems are effectively resolved and investigations are fully documented. Instigate and implement effective CAPA and where appropriate develop quality plans.
- Conduct approval, surveillance and internal audits in line with the requirements of MDSAP, including ISO 13485:2016 per the defined approved audit plans.
- Where required, carry out capability assessments of potential manufacturers / suppliers
- Support and contribute to the supplier approval process
- Work to and help continued development of the Quality Management System and process improvements.
- To support responses to the Competent Authorities and Regulatory Agencies in relation to Adverse Events. Ensure complaints are reported and closed in a timely manner
- Support the development, monitoring and reporting on metrics and KPI's needed to gauge the performance of the Business Management System
- To support and promote Quality Assurance strategy
Skills and experienced required:
- Educated to at least Degree Level in a relevant discipline or equivalent work experience
- A demonstrable strong working knowledge and experience of applying MDSAP / ISO 13485:2016 within the Medical Device Industry
- ISO 13485:2016 Auditor qualified or equivalent auditing experience.
- Excellent written communication skills - including report writing, CAPA investigations and quality plans.
- Excellent verbal communication skills - communicating technical and CAPA investigation with manufacturers and suppliers, colleagues and Top Management.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.