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.