Manufacturing Quality Engineer
Inspiration Healthcare Group
Location
Crawley, West Sussex | United Kingdom
Job description
Job Purpose (Role Definition) :
The Manufacturing Quality Engineer is responsible for:
- ensuring the implementation of process and their compliance to ISO 13485 and MDSAP;
- for developing, implementing, and maintaining quality assurance processes and supporting the
- Manufacturing Quality Team Lead on the promotion and awareness of Quality;
- is responsible for supporting the Manufacturing Quality Team Lead on quality compliance culture within the Group ensuring that all staff are aware of the Companies’ Quality Management System processes and the need to adhere to them.
Main Duties and Responsibilities
- Provide support to Research and Development with NPI/project based activities;
- Ensure quality processes needed for the Business Management System within the Group are documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR);
- Support the promotion of quality awareness of applicable quality requirements and Business Management System requirements throughout the Group;
- Conduct internal and external audits per the audit schedule;
- Reviewing non-conformance products on RED ZONE team meetings;
- Conducting investigation of production problems to identify, root causes, corrective actions and deliver preventative measures.
- Provide analysis and trends of nonconformities reported from production and support the Manufacturing Quality Team to implement preventative measures for identified trends.
- Ensure compliance to all applicable quality standards, regulations and internal procedures by proactively interpreting Quality requirements, and devising and implementing solutions to support the maintenance and enhancement of the Business Management System quality documentation;
- Support Quality Control processes;
- Support Supplier Quality Assurance team (SQA);
- Liaise with other Quality Assurance and Regulatory Affairs team members to present Quality issues that may affect the Group;
- Travel to all sites may be required.
MANAGEMENT RESPONSIBILITIES
None
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Job tags
Salary
