Quality Engineer II
hace 7 días
Cambridge
Job Title: Quality Engineer II Location: Cambridge, UK Duration: 12 Months Work Type : Hybrid Overview: TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation. Job Description: • This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in client location., • The incumbent will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle., • This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the organisation. POSITION RESPONSIBILITIES • Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures., • Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects., • Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external., • Provide input and support to design validation including, but not limited to, human factors engineering assessments., • Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply., • Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture., • Support the generation of all regulatory submission data and content for assigned device projects., • Support internal and external audits of the DCoE Quality Management System. EDUCATION, SKILLS AND EXPERIENCE • BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries, • OR MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline)., • History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation., • Experience in design controls and risk management for combination products., • Familiar with Human Factors Engineering - Usability Engineering., • Familiar with device assembling manufacturing processes. TECHNICAL SKILLS REQUIREMENTS. • Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation., • Familiarity with EN 62366, EN 60601, and EN 62304., • Able to learn and apply established procedures in a reliable and consistent manner., • Capable of working independently with minimal supervision., • High level of attention to technical details and accuracy., • Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously., • Able to work collaboratively in cross functional teams., • Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills., • Proficiency in general computer software such as word processing, spreadsheets, presentations., • Understand Good Manufacturing Practices (GMP). PHYSICAL POSITION REQUIREMENTS • Sitting, ability to travel TekWissen® Group is an equal opportunity employer supporting workforce diversity.