Quality Engineer

07 Aug 2016
21 Oct 2016
Contract Type
As a Quality Engineer, you will have a practical role in the day to day operation of the Quality Assurance - Solutions Team. This will include working in preparation for successful audits and inspections, maintaining and updating SOPs and processes, conducting Internal Audits, Quality Risk Management and supporting projects. You will build a detailed understanding of the individual elements that combine to create a successful Quality Unit, developing this understanding into efficient management processes that can deliver consistent results and compliance. Qualifications BS in Computer Science, systems engineering or related Engineering degree preferred. Proven experience in new product development and supporting software development and quality engineering related activities in a medical device environment. Proven Track record of conformance to regulatory requirements including as appropriate ISO 13485, ISO 14971, ISO 62304 and 21 CFR part 820. Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment. Knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to support software product quality for new and existing product development. Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality, wants to provide “added value”. Exceptional interpersonal and communication skills. Excellent attention to detail. Ability to work on one's own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills. Change Agent - supports continuous improvement / compliance to regulations. Work as an integral member of a cross functional team to support development and implementation of medical device software. Experience of working with ‘Agile' methodologies. Knowledge of Lean and 6 sigma tools and techniques as required including DFMEA, PFMEA SPC, design of experiments and root cause analysis (DMAIC,8D) Certified Lead Auditor ISO 13485 / 9001 Responsibilities Assessment of product medical compliance with ISO 13485, ISO 14971, ISO 62304 and applicable good manufacturing practice regulations including, 21 CFR part 820 within Elekta Ltd. The position is responsible for the ongoing development, implementation and maintenance of the Business Management System and compliance to Regulatory Systems/Standards. Ensuring conformance to regulatory requirements including as appropriate ISO 13485, ISO 14971, ISO 62304 and 21 CFR part 820 Ensure new products meet customer requirements /specifications with internal Elekta Ltd policies and procedures Provide support and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance. Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support medical device product software development (planning, requirements, architecture, verification/validation etc.) including software risk management, maintenance, configuration management and problem resolution. Work cross functionally and within Elekta Ltd Quality Assurance Solutions to support activities and potential improvement work is aligned and harmonized. Support the Head Quality Assurance - Solutions Crawley in deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the Business Management System. Proactively escalate issues and risks appropriately through appropriate channels to Head Quality - Solutions Crawley Support Manufacturing to ensure quality issues are dealt with and closed out in a timely manner. Support the closure of Non Conformities are completed and follow up actions and documentation including are closed out in a timely manner. This can include actions resulting from product or material quarantine, product or material rejects/returns. Support process improvement activities and projects Ensure internal audits of the Business Management System is carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement. Follow up planned audits and corrective actions Documentation management: Quality manual, SOPs and work instructions Support Process Owners to implement improvements into applicable procedures; follow-up their implementation and their efficiency with the appropriate indicators Support the development, monitoring and reporting on metrics needed to gauge the performance of the Business Management System Authorities: Execution of global & local QA strategies and policies as defined in the departmental business plan. Grant exemptions to Business System requirements on a local level. Execution of audits and preparation of audit reports. Issue and change processes and procedures. Approval of Deviation Reports