Quality Assurance Engineer

Job Description

Quality Engineer - Medical DevicesEdinburgh£33-37K per annumSearch Scientific are seeking to hire a Quality Engineer for a multi national organisation within medical devices. My client helps deliver products that have a profound impact on peoples lives. Now, more than ever, they are making an impact supporting products used in the fight against COVID-19.A global team of over 19,000 Engineering, Manufacturing, Supply Chain and Aftermarket Service experts that partner with our customers to bring their products to life through inspired innovation and world-class customer service.The Quality Engineer successful candidate shall be responsible for the day to day QUALITY MANAGEMENT SYSTEM activities associated with the product life cycle of medical devices and product design and development. Being in a design services environment we are looking for enthusiastic and articulate individuals who can focus on exceeding the needs of our customers and enjoy a large variety of product design challenges.Experience required:- A basic understanding (or willingness to learn about) of medical device design and development product life cycle process, ISO 13485, ISO 14971, and FDA 21CFR Part 820.- A degree level education within an engineering field.- Strong organization skills and high-level attention to detail.- Ability to work across multi-disciplinary teams to support delivery of projects.Job Role:- Develop strong working knowledge of the Quality Management System.- Develop an understanding of products in development, potential risks associated with design, and product use.- Support all design and development, design control, and risk management activities for full product lifecycle.Skills:- Analytical skills - spot problems quickly and find the underlying causes - Critical thinking - once problems are identified, solutions and improvements must be found; this might involve thinking about a process, procedure or problem in a completely new way- Numerical skills - statistical analysis - Communications skills - strong written and verbal communication skills are key. Must be able to relay potentially complex ideas to a wide range of audiences - both in personal consultations but also through company SOPs and quality documentation.- Team working skills - working as part of the quality team, and in close coordination with other teams throughout the engineering facility (as well as potential for interaction with manufacturing, suppliers, and customers) is a key part of quality engineering- Quality System processes - experience in implementation, management and improvement QS processes (e.g. Calibration, Internal Audit, NC, CAPA, Change Control) gained in a quality engineering/assurance function within the medical device industry- Knowledge of Quality Concepts (e.g. Traceability, Risk Management, CAPA, Audits, Statistics)- Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)- Computer literacyIf you would like to apply for this role please use the link provided below. Alternatively, please email a copy of your CV to Mukesh Dhir -Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age. Required skills

Keyskills :
medical device OR mee=dical devices OR QA Engineer OR quality engineer OR quality assurance OR ISO13485 OR FDA