Quality Engineer
- Recruiter
- Confidential
- Location
- Cambridge
- Salary
- 40000.00 - 50000.00 GBP Annual
- Posted
- 24 Jun 2022
- Closes
- 22 Jul 2022
- Sectors
- Engineering
- Contract Type
- Permanent
- Hours
- Full Time
Quality Engineer - IVD
SRG are currently recruiting for a Quality Engineer to join a rapidly growing IVD company in Cambridgeshire on a permanent basis at a salary of circa GBP45,000 p/a, depending on experience.
Reporting to the Quality Manager, this role will involve supporting the continued development and implementation of the Quality Management System and the work to achieve ISO 13485:2016 Certification.
Responisbilities will include;
* Lead the day-to-day management of the Quality Management System (QMS)
* Provide guidance and support across the wider organisation on ISO13485 and/or FDA 21 CFR 820 requirements
* Support the implementation, optimisation, and training of the QMS at all sites across the wider organisation
* Implement and maintain metrics for the continued compliance monitoring and improvement of the QMS (aligned to company objectives)
* Support the introduction and maintenance of suppliers and contract manufacturers in accordance with the QMS
* Provide guidance and support to all key stakeholders on product quality issues as requested
* Provide support to the generation and evaluation of product test data to support product development and continuous improvement
* Manage and co-ordinate validation of product manufacturing equipment
* Manage and drive solutions through Post Market Surveillance and CAPA for in-market product complaints
Qualifications, Skills and Experience;
* Degree within relevant scientific or engineering field
* Experience of managing CAPA and related investigations
* Experience of management of complaints from intake through to investigation and reporting
* Validation experience and expertise (especially in Computer Systems and Equipment)
* Overall management of the Manufacturing Quality activities (e.g. Batch records and traceability)
* Storage, Handling and Distribution systems within the QMS
* Liaising with external parties (e.g. Contract Manufacturer) to maintain the product and process compliance
* Able to generate technical documentation, write protocols and reports
* Creative thinking to resolve technical challenges
* Proficient in Microsoft Office suite
* Hands-on approach and basic workshop skills
* Motivated by the prospect of working in a fast-paced start-up environment
* Eager to learn new skills as well as implement those they have
* High standard of written and spoken English
For more information, please contact Laith Mustafa on (phone number removed) or apply
SRG are currently recruiting for a Quality Engineer to join a rapidly growing IVD company in Cambridgeshire on a permanent basis at a salary of circa GBP45,000 p/a, depending on experience.
Reporting to the Quality Manager, this role will involve supporting the continued development and implementation of the Quality Management System and the work to achieve ISO 13485:2016 Certification.
Responisbilities will include;
* Lead the day-to-day management of the Quality Management System (QMS)
* Provide guidance and support across the wider organisation on ISO13485 and/or FDA 21 CFR 820 requirements
* Support the implementation, optimisation, and training of the QMS at all sites across the wider organisation
* Implement and maintain metrics for the continued compliance monitoring and improvement of the QMS (aligned to company objectives)
* Support the introduction and maintenance of suppliers and contract manufacturers in accordance with the QMS
* Provide guidance and support to all key stakeholders on product quality issues as requested
* Provide support to the generation and evaluation of product test data to support product development and continuous improvement
* Manage and co-ordinate validation of product manufacturing equipment
* Manage and drive solutions through Post Market Surveillance and CAPA for in-market product complaints
Qualifications, Skills and Experience;
* Degree within relevant scientific or engineering field
* Experience of managing CAPA and related investigations
* Experience of management of complaints from intake through to investigation and reporting
* Validation experience and expertise (especially in Computer Systems and Equipment)
* Overall management of the Manufacturing Quality activities (e.g. Batch records and traceability)
* Storage, Handling and Distribution systems within the QMS
* Liaising with external parties (e.g. Contract Manufacturer) to maintain the product and process compliance
* Able to generate technical documentation, write protocols and reports
* Creative thinking to resolve technical challenges
* Proficient in Microsoft Office suite
* Hands-on approach and basic workshop skills
* Motivated by the prospect of working in a fast-paced start-up environment
* Eager to learn new skills as well as implement those they have
* High standard of written and spoken English
For more information, please contact Laith Mustafa on (phone number removed) or apply