|Location: Birmingham, West Midlands||Salary: + Ben's|
|Sector: Medical Devices||Specialism:|
|Type: Permanent||Contact: Ben Abbott|
Are you looking to join a forward thinking revolutionary Medical Solutions company that's has doubled its market share in the last 5 years and plans to double again in the next 5 years then please listen carefully.
Ideally you will have worked in one of the following industuries: Pharmaceutical, Medical or IVD, However if you have experinece with ISO9001 and would like to get into the medical sector my client is willing to provide great training to get you up to speed such as 13485, FDA part 820 regulations, Risk Assessment, Lean Six Sigma etc. With the company growing and expanding its product base there will be plenty of career progression opportunities not just here in the UK but internationally as well. My client operates in over 90 countries worldwide.
The successful Quality Engineer will want to work for this client not just because it's a great opportunity but also because they will give you a wealth of benefits including:
* Salary: Competitive
* 25 day's holiday
* Annual bonus
* Pension Plan
* Career Progression
* Child care vouchers
* Cycle scheme
* Life assurance
* Plus more
Some of the main duties of the Quality Enigneer will include:
* To ensure that the quality management system in manufacturing meets all requirements of all relevant regulatory standards and Regulations: ( ISO9001/13485, FDA CFR 820 part 21 , QSR's)
* To work within the QA team located in manufacturing to ensure the company maintains compliance to external and internal quality system requirements.
* To work alongside manufacturing teams and advise on quality related issues/ day to day issues. Quality Engineer in manufacturing is responsible for assuring that manufacturing processes are in compliance with ISO/cGMP Quality Management System to produce consistent quality product.
* Reporting to the Quality Engineering Manager, The Quality Engineer is also responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes resulting in improved metrics such as Overall Equipment Effectiveness (OEE), Scrap reduction and ability to leverage increased quality for delivery performance improvements, etc. problems arising in day-to-day work and fix these issues.
In order to be the successful Quality Engineer and have a chance to gain such an exciting opportunity you will ideally need to have the following:
* A level or equivalent
* Working knowledge of FDA part 820, ISO 13485
* Experience of NCR/CAPA
* Experience of working within QA Engineering or manufacturing QA position in a manufacturing environment within the IVD or Medical Device Industry/ or regulatory industry
* Strong communication skills both written and verbal.
* Good understanding for Quality principles / Quality systems.
* Experience of non-conforming product and corrective action processes.
* Problem solver.
* Degree or equivalent in Biological sciences or similar
* Quality Assurance/ manufacturing engineering background
* Working knowledge/experience of PFMEA,
* Risk management to ISO 14791.
* Experience in validation.
* Knowledge quality tools.
This really is a fantastic opportunity for a Quality Engineer to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!