Validation Engineer

Validation Quality Engineer - Medical Devices
£45k - £50k per year + benefits including flexi-start/finish times, bonus & Perkbox
Suffolk
Serve Talent have partnered with a successful Engineering business to recruit a Validation Quality Engineer for their site in Saxmundham, Suffolk.
Reporting into the Quality Manager, you'll assist the Quality Manager with all things Validation & Quality related across the business which include document quality investigations, production quality issues, validation reports and also improving processes.
As part of the development of these medical devices, the quality department play a key role. Some of these devices could potentially save peoples lives so making sure the t's are crossed and the i's dotted is essential.
Responsibilities will include but not be limited to:

- Maintain the companies QMS to meet standards such as ISO 13485, MDR, UKCA and cGMP/FDA.
- Perform quality and engineering investigations using tools and techniques relevant to the medical device industry and modern manufacturing such as risk management, process validation, continuous improvement and lean six sigma techniques.
- Where necessary, perform accurate mechanical, physical and visual inspection of in-coming raw materials, in-process and finished products as per inspection plans and specification requirements.
- Write and review cGMP documentation as well as implementing new documents where necessary
Ideally you'll have:

- Knowledge & an understanding of Validation within a Medical Device environment.
- Hold knowledge of and understand quality standards and models preferably gained in a medical device industry or alternatively in other suitable industries such as automotive or aerospace.
- The ability to write technical quality records such as validation plans and reports.
- Have experience in quality tools and techniques, including process validation (IQ / OQ / PQ), FMEA, etc.
- Relevant degree qualification, or HNC / HND and ideally ISO13485 Lead Auditor (preferable) or Internal Auditor trained.
This is a fantastic opportunity for a Quality focused person to take the next step in their career, by joining an established team of experienced individuals and developing your career long term.
Alongside a competitive salary and benefits package, is a carved out career development plan with significant scope for promotion and development for those who want it. Benefits include Flexible start/finish times, 40 hour working weeks, PerkBox benefits package,30 days holiday (including bank holidays) and annual bonus.