Medical Device Design Process Quality Assurance Engineer – Hertfordshire
Opportunity:
This is a great opportunity for someone with good design control, risk management and process development medical device experience to join a global company with great career development.
Your role as a Medical Device Design Process Quality Assurance Engineer based in Hertfordshire will involve being responsible for the design control assurance and risk management support for the development of new products throughout the product lifecycle.
You will provide quality engineering and process excellence support for existing products covering supply chain, production and post-production processes as well as organise and facilitate continuous improvement activities to improve process efficiency, product compliance and control.
Other duties and responsibilities include:
• Maintain design history files, data trending and analysis.
• Define, interpret and classify critical quality characteristics for new products and processes.
• Produce and maintain appropriate and comprehensive quality and control plans as required during the development and implementation of new products/technologies/processes.
• Utilize best practices for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance.
• Define, identify, and apply product and process control methods e.g. control plans, identifying critical control points, developing and validating work instructions.
• Participate in design and process evaluations including development of material and product specifications, test methods and risk analysis (e.g. DFMEA, PFMEA).
• Provide technical assistance to carry out problem analysis/complaint investigation where necessary, e.g. CAPA & NCR investigation and closeout.
• Supplier quality assurance development.
• Identify and introduce suitable test and inspection methods using appropriate equipment and gauging and benchmark against best practice and relevant standards.
• Identify, review and apply metrology techniques including measurement system analysis and calibration control.
• Review, approve, and manage documents, e.g. validation protocols, SOP’s, specifications for accuracy and completeness; generate/revise documents as needed.
This is a full time permanent role.
Skills:
To apply for the role of Medical Device Design Process Quality Assurance Engineer you will have the following:
• Degree or equivalent qualification in an engineering, scientific or technical subject.
• Medical device experience.
• Ideally application of design control and risk management (ISO 14971) principles.
• Ideally experience in developing design history files for medical devices.
How to Apply:
If this sounds like the role for you or a colleague then please don’t hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit www.qualitystart.co.uk
My contact details are:
Miss Rashida Khan
0113 225 1547
rashida@qualitystart.co.uk
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
