Quality Engineer – Class III Medical Devices – North London
An exciting opportunity has arisen with an innovative, R&D driven medical technology organisation that are backed by a world leading healthcare business.
They are world leaders within their field and are now looking to expand by appointing a Quality Engineer to supplement their extensive Quality department. This is a permanent opportunity with significant scope for personal development and growth within an expanding business.
Overall Responsibilities
- Provision of design control assurance and risk management support for the development of new products throughout the product lifecycle
· Provision of quality engineering and process excellence support for existing products covering supply chain, production and post-production processes
- Organizing and facilitating continuous improvement activities to improve process efficiency, product compliance and control
Duties and Responsibilities
· Provide quality assurance support throughout the design control and risk management process for the development and introduction of new products
- Provide technical assessment of data that supports the design history files including the review of product designs and test protocols
- 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
- Support supplier development and supply assurance for designated components and materials
- 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
- Participate in cross-functional teams that impact product quality, time to market, increase efficiency, solve problems, generate cost savings, improve quality, and provide new concepts
- Participate in continuous improvement initiatives such as QLP, Bioscience Operating Systems, Lean and Six Sigma
- Track and trend department metrics, KPI and quality indicators
- Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures for area of responsibility
- Review, approve, and manage documents, e.g. validation protocols, SOP’s, specifications for accuracy and completeness; generate/revise documents as needed
· Keep updated with trends through attendance at related conferences, seminars, and other training methods
Requirements
The successful applicant will possess the following attributes:
· Degree or equivalent qualification in an engineering, scientific or technical subject
· Medical device experience – ideally class III 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 for class III medical device products
· Experience in developing design history files for medical devices
For further information please contract John Bowler at Hays Life Sciences:
0203 465 0063
You must possess current eligibility to live and work in the UK without restriction. Unfortunately sponsorship is not available.