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Job Description

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 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 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 .

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