Quality Engineer 12 months contract Cambridge site – 2-3 days p/w on site (5 days per fortnight) PAYE rate max up to £21.62 p/h Umbrella rate max up to £24.23 p/h This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in Cambridge, UK.
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, driving license.
COMPETENCIES COMPETENCY DETAIL Decisive Is an agile learner who synthesizes complex information to determine the best course of action.
Focused Holds self and others accountable for consistently meeting needs of customers and stakeholders.
Connected Builds effective professional relationships with internal and external stakeholders.
Courageous Shows consistency between words and actions, gaining people's trust and respect.
Resilient Adapts or shifts priorities in response to the needs of clients, constituents, or the organization