Quality Engineer

Quality Engineer - Quality - Medical Devices - Bioscience - Contract - North London - 6 too 12 months

A fantastic opportunity has become available within a medical devices company in North London.
A 12 month contract for a Quality Engineer with a highly regarded Medical Devices company who are part of a larger Pharmaceutical company. You will be working on an exciting new product alongside other skilled Quality Professionals.

The role will involve:

Providing quality engineering, design control assurance and risk management support for the development of new products throughout the product life-cycle.
Supplying quality engineering and process excellence support for existing products covering supply chain and all stages of production.
Participating and lead where necessary continuous improvement activities to improve product compliance, control and process efficiency.
Providing technical assessment of data that supports the design history files. Responsible for the maintenance of the design history files
Producing and maintaining appropriate and comprehensive quality plans as required during the development and implementation of new technologies/processes
Reviewing product designs, test protocols and co-develop critical characteristics/tolerances for testing and validation and subsequent routine manufacturing control
Providing technical assistance to carry out problem analysis/complaint investigation where necessary, e.g. CAPA & NCR investigation and closeout
Participating in continuous improvement initiatives such as QLP, Bioscience Operating Systems, Lean and Six Sigma

To apply for this role you must have:

A Degree or equivalent qualification in an engineering, scientific or technical subject.
At least 3 years GMP medical device experience - ideally class 3 devices
Experience in the Quality Engineering of medical technology
Proven track record in delivering compliance & continuous improvement projects
Experience working to ISO 13485 and FDA compliant systems
Application of design control and risk management (ISO 14971) principles
Experience in developing design history files for medical devices

You must also have:

The ability to interpret engineering drawings and specifications
Familiarity with applicable test approaches, inspection techniques and sampling plans
The ability to review data, monitor data trends and apply statistical techniques
Investigational and problem solving skills - root cause analysis
Application of quality engineering tools and concepts such as DFMEA, PFMEA, DOE, SPC, Six Sigma, DMAIC, Lean etc.
Ability to effectively review facilities, process and test method validation protocols within a regulated industry
Capability to identify and apply appropriate calibration techniques for gauging and test equipment
Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.

In addition to gaining valuable experience within this world leading medical devices company, you will also be offered competitive rates or pay, and the option for relocation to North London.

Key words - Quality Engineer, Quality, Quality Management Systems, ISO 13484, ISO 14971, Test Method, Validation, Design Control, Risk Management, CAPA, Medical Devices, Bioscience, Contract, North London,
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