Senior Quality Engineer

Job Description

Senior Quality EngineerRemote Role (Head office Based out of London)Our client is a Global Medical Device Organisation who is presently looking for a Senior Quality Engineer to join its UK team to support its award-winning touch surgery application and web platform in its Digital Surgery division. Digital Surgery has createda digital data-driven ecosystem that uses cutting-edge gorchestrate surgical teams in the operating room (OR) and deliver safer surgery around the world. To deliver the best possible products they are looking for a Sr. Quality Engineer to work collaborativelywith cross-functional teams.R&D is at the heart of Digital Surgery - within the organisation, the Sr. Quality Engineer will lead the team through the new product development process, provide guidance on technical design, and implement strategies that drive product quality/continuousimprovement. Additionally, this individual will aid in the development of processes that meet applicable regulations and ensure agility and efficiency in the development process. They will lead, direct, and organize Quality activities from Design Concept throughDesign Transfer as well as support Post Market activities.Responsibilities will include the following:

• Overall responsibility for integrating/implementing an ISO13485 compliant quality management system.
• Responsible for training cross-functional team members on design and development processes and leading the team through new product development for an electromechanical medical device with embedded software.
• Collaborate with cross-functional team members to develop processes that are compliant to applicable regulatory requirements and allow for agility and efficiency.
• Collaborate with cross-functional team members to optimize processes for non-medical device products (in addition to medical device products).
• Lead investigations for failures in the field for existing non-medical device product(s) and future medical device product(s)
• Guide the cross-functional team through the product development process (e.g. Design Input, Design Output, Design Verification, Design Validation, and Design Transfer).
• Develop and maintain constructive working relationships with cross-functional team members, including but not limited to R&D, Operations, Marketing, Product, and Regulatory.

Must have:

• Bachelor of Science Degree in Biomedical, Mechanical, Electrical, Software, or other related fields
• Minimum of 4 years of relevant experience
• Experience with Electromechanical Software-Enabled Medical Devices.
• Working knowledge of standards applicable to Medical Device Safety/Risk
• Management (i.e. ISO13485, ISO14971, IEC 60601-1, US 21 CFR Part 820,etc.)

Nice to have:

• Strong verbal and written communication skills; ability to present issues, communicate plans and solutions.
• Flexibility and an eagerness to work within a rapidly growing team with changing
• Excellent organisational, problem solving, and analytical skills.
• Experience with the following software suites: Matlab, Minitab
• Experience applying Risk Management tools (Hazard Analysis, Risk Analysis, Fault Tree Analysis, Use Error Analysis, etc.)
• Experience applying root cause analysis tools (Fishbone charts, 5 Whys, DMAIC, etc.)
• Green or Black Belt Six Sigma Certification (DFSS or DMAIC).

Keyskills :
Quality AssuranceRoot Cause AnalysisISO13485Electromechanical Software